AU2010214690B2 - Mobile bearing knee prosthesis - Google Patents

Abstract

A mobile bearing knee prosthesis enables a surgeon to convert a mobile bearing insert having articular surfaces, supported by a tibial 5 baseplate or tray from a rotating and translating prosthesis to one that rotates only. This conversion is accomplished with a fastener or locking member that connects through an opening in the insert to the tibial baseplate. This proximal can be used as part of a total knee surgery when the surgeon chooses to use a prosthesis that incorporates a movable 10 articular surface. In one embodiment, a projecting portion extends proximally from the insert and cooperates with a cam on the femoral component. The projecting can be a post extending up from the proximal surface of the insert and the femoral component includes an intercondylar surface that may contact the post to constrain the relative motion between 15 the femoral component and the insert. In another embodiment, the insert is a two part assembly that includes a larger member with a central opening and a smaller member that fits the opening. FIG. 2 FIG.3

Description

Australian Patents Act 1990 - Regulation 3.2A ORIGINAL COMPLETE SPECIFICATION STANDARD PATENT Invention Title "Mobile bearing knee prosthesis" The following statement is a full description of this invention, including the best method of performing it known to us:- C:\NRPortbl\DCC\TXB\4776067_1.DOC - 29/11112 MOBILE BEARING KNEE PROSTHESIS The present invention relates to orthopaedic prosthetic devices, and more particularly to an improved rotating platform, mobile knee prosthesis 5 that incorporates anterior stabilization along with the ability to constrain the movement of the articular surface from rotation and translation, to rotation only. Femoral rollback is believed to improve range of motion and extensor mechanism leverage so as to improve efficiency and more accurately 10 replicate natural kinematics. Conventional mobile bearing designs may lack the desired effect of femoral rollback, particularly in the absence of the posterior cruciate ligament. Posterior Stabilized (PS) fixed bearing designs provide femoral rollback by articulating a cam on the femoral component with a post on the 15 tibial articular insert during flexion. However, PS fixed bearing designs do not have the advantages of mobile bearing designs with regards to enhanced range of motion, reduced rehabilitation time, improved patellofemoral alignment, increased contact area, and reduced bone implant interface shear forces. 20 In fixed bearing designs, excessive wear of the PS post can occur during articulation with the femoral cam. Internal-external rotation of the femoral component reduces the PS post-femoral cam congruency which increases contact stresses. The increased contact stresses can lead to excessive polyethylene wear and component failure. Allowing the PS post 25 to rotate within a fixed articular insert will maintain femoral cam-PS post congruency during internal-external rotation of the femoral component. Further, in any type of posterior stabilized design (fixed bearing or mobile bearing), one of the most problematic failure modes of the polyethylene is the fracture of the central post of the insert. This failure can 2 be attributed to "notching" the anterior side of the central post with the anterior most inner-condylar area of the femoral component. Thus, any mechanism to reduce the probability for impingement of the femoral component against the anterior side of the tibial central post in hyper 5 extension would reduce the probability for tibial insert post failure due to "notching" and ultimately breaking. Previous rotating platform designs have incorporated rotating only, or rotation and translation through the use of different prostheses. An 10 example of a prosthesis that rotates and translates is shown in British publication 2219942, entitled "Knee Prosthesis". US 5,906,643 provides a tibial baseplate with a post that protrudes through a meniscal component and articulates with a cam on a femoral component. The post is an integral part of the tibial baseplate. 15 US 5,879,392 provides a tibial baseplate with a fixed post that extrudes through the stem of the tibial baseplate and through the bearing component and articulates with a recess within the femoral component. 20 EP 0916321 A2 provides a femoral component with transverse flanges on the medial and lateral surfaces of the posterior stabilized box that articulates with projections from the medial and lateral surfaces of the post. 25 WO 95/35484 provides a bearing component with a post that articulates with a recess within the femoral component. The bearing component is limited in rotational, anterior, and posterior movement with respect to the tibial component. 30 The following patents relate to other orthopaedic prosthetic devices, many of the listed patents pertaining to a knee prosthesis: 3 Patent # Issue Date Title 3,899,796 08/19/75 Metacarpophalangeal Joint 4,016,606 04/12/77 Knee Joint Prosthesis 4,094,017 06/13/78 Knee Joint Prosthesis with Patellar-Femoral Contact 4,216,549 08/12/80 Semi-Stable Total Knee Prosthesis 4,224,697 09/30/80 Constrained Prosthetic Knee 4,257,129 03/24/81 Prosthetic Knee Joint Tibial Implant 4,340,978 07/27/82 New Jersey Meniscal Bearing Knee Replacement 4,673,407 06/16/87 Joint-Replacement Prosthetic Device 4,822,366 04/18/89 Modular Knee Prosthesis 4,936,853 06/26/90 Modular Knee Prosthesis 4,950,297 08/21/90 Knee Prosthesis 4,959,071 09/25/90 Partially Stabilized Knee Prosthesis 5,007,933 04/16/91 Modular Knee Prosthesis System 5,032,132 07/16/91 Glenoid Component 5,071,438 12/10/91 Tibial Prosthesis With Pivoting Articulating Surface 5,116,375 05/23/92 Knee Prosthesis 5,271,747 12/21/93 Meniscus Platform for an Artificial Knee Joint 5,282,868 02/01/94 Prosthetic Arrangement for a Complex Joint, Especially Knee Joint 5,314,483 05/24/94 Meniscus Platform for an Artificial Knee Joint 5,344,460 09/06/94 Prosthesis System 5,370,699 12/06/94 Modular Knee Joint Prosthesis 5,387,240 02/07/95 Floating Bearing Prosthetic Knee C.NRPortbl\DCC\TX8\4776067_1.DOC - 29/11/12 -4 5,395,401 03/07/95 Prosthetic Device for a Complex Joint 5,404,398 04/11/95 Prosthetic Knee With Posterior Stabilized Femoral Component 5,413,604 05/09/95 Prosthetic Knee Implant for an Anterior Cruciate Ligament Deficient Total Knee Replacement 5,413,608 05/09/95 Knee Joint Endoprosthesis for Replacing the Articular Surfaces of the Tibia 5,549,686 08/27/96 Knee Prosthesis Having a Tapered Cam 5,609,639 03/11/97 Prosthesis for Knee Replacement 5,658,342 08/19/97 Stabilized Prosthetic Knee 5,702,466 12/30/97 Rotational and Translational Bearing Combination in Biological Joint Replacement 5,782,925 07/21/98 Knee Implant Rotational Alignment Apparatus 5,871,543 02/16/99 Tibial Prosthesis With Mobile Bearing Member 5,871,545 02/16/99 Prosthetic Knee Joint Device 5,935,173 08/10/99 Knee Prosthesis It would be desirable to enable a surgeon to convert a mobile bearing articular surface on a knee prosthesis from a fixed to a rotating only or translating only, or even to allow for rotation and translation simultaneously. 5 Translation only does not mimic the natural motion of the knee. There however, may be exceptions to the rule. The normal knee translates and rotates. In use of a mobile bearing knee replacement, there are times when the secondary soft tissue structure is compromised so that use of an insert that allows both translation and rotation results in unacceptable instability. 10 In that case an insert with rotation only is preferred because rotation serves to reduce shear stress at the fixation surface and reduce contact stress at C:NRPortbl\DCC\TXB\4776067_1. DOC -29/11112 -5 the articular surface, but there is more stability due to the anterioposterior constraint. In most knee designs rotational malalignment at the articular surface results in a higher contact stress than pure translational malalignment. 5 Rotational freedom has more benefit than translational freedom in reducing the potential for fatigue wear. In embodiments of the invention, these conversions are accomplished with special locking members or plugs that connect to a tibial base special plate. The locking members can be secured to the baseplate with a taper 10 lock or a threaded connection for example. In embodiments of the invention, a post on the proximal tibial base plate can be positioned with an offset with respect to an oval hole in the articular insert to provide anterior stabilization in the total knee prosthesis. The prosthesis of the present invention will be used as part of a total 15 knee surgery when the surgeon chooses to use a prosthesis that incorporates a particular, selected relative motion between tibial components. In embodiments, the present invention provides a posterior stabilized PS post which is secured to the mobile bearing tibial baseplate allowing 20 only rotational movement. The PS post captures a bearing component to the tibial baseplate through an elongated slot in the bearing component. The elongated slot in the bearing component allows it to translate anteriorly and posteriorly with respect to the posterior stabilized post. The bearing component may also rotate with respect to the tibial baseplate in 25 conjunction with the PS post. The bearing component has two concave surfaces that are articulate with the convex surfaces of the femoral component, and that are roughly congruent with the convex surfaces of the femoral component at zero degrees of flexion or full extension. The PS C:\NRPortbkDCC\TXB\4776067i- DOC - 29111/12 -6 post articulates with a recess or cam of the femoral component to provide femoral rollback. In addition to the above described design, in embodiments the PS post should allow for posterior translation, in addition to rotational 5 movement. This posterior movement would allow the post to translate instead of impinging upon the inner-condylar notch area of the femoral component in hyper-extension. In embodiments of the invention, one or more of the following features may be present. The PS post has a flat distal surface that articulates with 10 the tibial baseplate. A T-slot is located on the distal end and articulates with a T-post on the tibial baseplate. A through hole in the PS post is located such that a rotation peg can capture the PS post to the tibial baseplate while the T-slot of the PS is engaged with the T-post of the tibial baseplate. The rotation peg allows only rotational freedom of the PS post 15 with respect to the tibial baseplate. The PS post has a flange on the medial and lateral surfaces that capture the bearing component through a counterbore on the medial and lateral sides of an elongated slot of the bearing component. The elongated slot of the bearing component is larger than the PS post in the anterior-posterior direction such that the bearing 20 component has limited translational with respect to the PS post. The bearing component may also rotate with respect to the tibial baseplate in conjunction with the PS post. The bearing component has two concave surfaces that are congruent to the convex surfaces of the femoral component. A cam mechanism on the femoral component can be a 25 concave cylinder that can be congruent to the convex posterior surface of the PS post. The internal/external rotation of the PS post with the femoral component can maintain this congruency throughout the range of motion unlike designs with a fixed PS post.

C:WRPortbl\DCC\TXBW776067_1.DOC -29/11/12 -7 In embodiments, the addition of the posterior translation can occur with an anterior to posterior "A/P" slot instead of a hole. This slot would allow for posterior translation of the post relative to the insert/baseplate. In embodiments, the PS post may engage the tibial baseplate through 5 a pin means or through a boss of a configuration other than a T-post. The PS post may secure the bearing component through the use of slots or other means of capture. The PS post may articulate with a closed recess within the femoral component rather than a cam mechanism. With the fixed bearing design, the means of PS post capture may be 10 with the use of a retaining ring or a cross pin. The PS post may not require capture with a fixed bearing articular insert. In embodiments, the present invention provides an improved knee prosthesis apparatus that includes a tibial prosthesis that is configured to be surgically implanted on a patient's transversely cut proximal tibia and a 15 femoral component. The femoral component articulates with a tibial insert having a proximal surface that engages the femoral component, the insert having a distal surface that fits against and articulates with the proximal surface of the tibial prosthesis. A constraining mechanism joins the tibial insert to the tibial prosthesis 20 in a selective fashion that enables a number of different possible relative motions between the insert and the tibial prosthesis, including anterior to posterior translation with rotation, or rotation only. All or part of the constraining mechanism may be separable from the tibial prosthesis, and selective removal of all or part of the constraining 25 mechanism determines which of the said possible relative motions will take place. The tibial prosthesis can have a fixator for holding the tibial prosthesis on a patient's proximal tibia, such as, for example, a stem, spike, cement, etc.

C:\NRPortbl\DCC\TXB\4776067_1.DOC -29/11/12 -8 The proximal surface of the insert can have one or more concavities for articulating with the femoral component. The femoral component can include an intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral 5 component and the insert to be constrained. According to the present invention there is provided a knee prosthesis apparatus comprising: a. a tibial component including a tibial tray portion configured to be surgically implanted on a patient's transversely cut proximal 10 tibia; b. a fixator for holding the tibial component on the patient's proximal tibia; c. a tibial insert having first and second removably connectable members, including a peripheral member having a central 15 opening and a central member that connects to the central opening, the insert having a distal surface that fits against and articulates with the proximal surface of the tibial component; d. a femoral component; e. a constraining mechanism that joins the insert to the tibial tray 20 portion during use in a selective fashion that enables a number of different possible relative motions between the insert and tibial tray portion, including anterior to posterior translation and rotation or rotation only; and f. wherein all or part of the constraining mechanism is separate 25 from the tibial tray portion and selective removal of all or part of the constraining mechanism determines which of the said possible relative motions will take place. In one particular embodiment of the invention, the constraining mechanism includes a post extending up from a proximal surface of the 30 tibial insert. In this embodiment, the femoral component may include an C:\NRPortblDCC\TXB\4776067_1.DOC - 29/111/12 intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral component and the tibial insert to be constrained. The central member may slidably connects to the peripheral member. 5 The central member may connect to the tibial tray portion and the peripheral member may connect to the central member. A proximal surface of the tibial insert may have one or more, for example two, concavities for articulating with the femoral component. In another particular embodiment the constraining mechanism 10 includes a post extending up from a proximal surface of the tibial tray portion. In this embodiment the central member may connect to the post. In both of the aforementioned particular embodiments, the post may have a socket and the constraining mechanism may include a locking plug member that is connectable to the socket on the post. 15 In a variation of said another particular embodiment, the constraining mechanism includes a post extending up from a proximal surface of the tibial tray portion, a slot on a distal surface of the tibial insert, an opening on a proximal surface of the tibial insert that communicates with the slot and a locking plug member that can access and connect to the post from the 20 proximal surface of the tibial insert via the opening. This variation may include any of the following features. The femoral component includes an intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral component and the tibial insert to be constrained. The constraining mechanism includes a 25 socket on the post that receives the locking plug member, wherein the locking plug member is attached to the post for further defining movement between the tibial insert and tibial tray portion. The opening is defined by C:\NRPortblDCC\TXB\4776067_1.DOC - 29/11/12 -10 an annular surface that fits closely to the locking plug member when the locking plug member is connected to the post. In embodiments of the invention the constraining mechanism includes an opening that extends from a proximal to a distal surface of the tibial 5 insert and a variety of connectable portions which are selectively attachable to or separable from the tibial tray portion, and wherein the geometry of the various connectable portions relative to the opening enables a user to determine which of the relative motions will take place. In another variation, the knee prosthesis of the invention further 10 comprises a. a post mounted at a central portion of a proximal surface of the tibial tray portion, the post having a socket; b. a generally vertical channel at a central portion of the tibial insert that extends through the tibial insert, the channel including an 15 elongated slot portion that extends a partial distance through the tibial insert, beginning at a distal surface of the tibial insert and terminating at a position intermediate a proximal surface of the tibial insert and the distal surface of the tibial insert, the elongated slot portion extending generally along an anterior to 20 posterior line; c. the elongated slot portion removably connecting to and sliding with respect to the post ; and d. a locking member for selectively locking the tibial insert and tibial tray portion together with a rotational connection, the locking 25 member extending through the tibial insert to connect with the post; wherein e. the tibial insert and tibial tray portion are configured to enable selected relative motion between them by respectively connecting or disconnecting the locking member, with the tibial - 10A insert being rotatable relative to the tibial tray portion when the locking member connects to the post; and f. the first and second connectable members are rotatable relative to the third tray portion when the locking member is assembled 5 with the post. Embodiments of this variation may include any of the following features. The constraining mechanism includes a post extending up from the proximal surface of the tibial insert, with the femoral component optionally including an intercondylar surface that is positioned to contact the 10 post extending up from the proximal surface of the tibial insert, enabling relative motion between the femoral component and the tibial insert to be constrained. In this arrangement, the channel may closely conform to the locking member at the proximal surface of the tibial insert. The first and second connectable members may be slidably connected during use. The 15 tibial insert has a post, with the post optionally having a socket that receives the locking member. The channel extends through the insert, communicating with both the proximal and distal surfaces of the tibial insert. In this arrangement the channel may have a larger transverse cross section at the distal surface of the tibial insert and a smaller transverse cross section at 20 the proximal surface of the tibial insert. The femoral component engages the tibial component. In embodiments of the invention, the femoral component articulates with the tibial insert. For knee flexion to be optimized, the femur must roll back on the tibia. 25 This means that the contact point between the femoral and tibial components moves posteriorly. In a one-piece mobile bearing PS design, roll back is caused by the contact of the bar of the femoral component on the post of the tibial insert. This contact tends to push the insert forward (relative to the tibia). In order for normal roll back (with respect to the tibia) - 1OB to occur, the bar and post design must compensate by causing the femur to roll back on the surface of the tibial insert (the contact point moves posteriorly on the insert). Movement of the contact point causes the stress levels to fluctuate and can lead to fatigue and adhesive wear of the 5 polyethylene. In a two piece tibial insert design, the post does not translate, but the insert does. This allows the insert to move posteriorly with the femoral component as the bar/post interaction dictates. However, since the insert moves with the femoral component, the contact point does not move 10 posteriorly on the tibial insert. This provides a more consistent stress level and reduces the tendency for fatigue and adhesive wear. For a further understanding of the nature, objects, and advantages of embodiments of the present invention, reference should be had to the following detailed description, read in conjunction with the following 15 drawings, wherein like reference numerals denote like elements and wherein: Fig. 1 is a perspective, exploded view of the preferred embodiment of the apparatus of the present invention; Fig. 2 is a partial sectional of the preferred embodiment of the 20 apparatus of the present invention illustrating the locking member portion thereof; 11 Fig. 3 is a top, fragmentary view of the preferred embodiment of the apparatus of the present invention illustrating the locking member portion thereof; Fig. 4 is a partial, elevational view of the preferred embodiment of the 5 apparatus of the present invention illustrating the locking member portion thereof; Fig. 5 is a rear, elevational and exploded view of the preferred embodiment of the apparatus of the present invention illustrating the articular polymeric insert and tray portions thereof; 10 Fig. 6 is a sectional, elevational view of the preferred embodiment of the apparatus of the present invention shown with the locking member removed; Fig. 7 is another sectional, elevational view of the preferred embodiment of the apparatus of the present invention illustrating the locking 15 member in operating position when only rotational movement is desired; Fig. 8 is a partial top view of the preferred embodiment of the apparatus of the present invention showing the polymeric insert; Fig. 9 is a partial, bottom view of the preferred embodiment of the apparatus of the present invention showing the polymeric insert; 20 Fig. 10 is partial rear view of the preferred embodiment of the apparatus of the present invention showing the polymeric insert; Fig. 11 is a partial sectional view of the preferred embodiment of the apparatus of the present invention taken along lines 11-11 of Fig.8; Fig. 12 is a sectional view of the preferred embodiment of the 25 apparatus of the present invention taken along lines 12-12 of Fig. 8; Fig. 13 is a partial top view of the preferred embodiment of the apparatus of the present invention illustrating the tray or baseplate; Fig. 14 is a sectional view of the preferred embodiment of the apparatus of the present invention taken along lines 14-14 of Fig. 13; 30 Fig. 15 is a top view of the preferred embodiment of the apparatus of the present invention illustrating the insert and tray portions thereof in operating position with the locking member; 12 Fig. 16 is a top side view of the preferred embodiment of the apparatus of the present invention illustrating the insert, tray and locking member portions thereof in operating position; Fig. 17 is a top view of the preferred embodiment of the apparatus of 5 the present invention illustrating rotation of the insert relative to the tray; Figs. 18 - 21 are fragmentary perspective views of an alternate embodiment of the apparatus of the present invention illustrating constructions for the post portion and illustrating the connection between the post and the tray; 10 Figs. 22 - 25 are schematic plan views of alternate constructions of the tibial insert to be used respectively with the post constructions of Figs. 18 -21; Fig. 26 is a top view of the second alternate embodiment of the apparatus of the present invention illustrating the tray portion thereof; 15 Fig. 27 is an elevational view of the second alternate embodiment of the apparatus of the present invention illustrating the tray portion thereof; Fig. 28 is a bottom view of the second alternate embodiment of the apparatus of the present invention illustrating the tray portion thereof; Fig. 29 is a plan view of the second embodiment of the apparatus of 20 the present invention illustrating the polymeric insert portions thereof; Fig. 30 is a frontal elevational view of the second alternate embodiment of the apparatus of the present invention illustrating the plastic insert portion thereof; Fig. 31 is a bottom view of the plastic insert portion of the second 25 alternate embodiment of the apparatus of the present invention; Fig. 32 is a fragmentary view of the second alternate embodiment illustrating the locking plug member portions thereof; Fig. 33 is a sectional view taken along lines 33 - 33 of Fig. 32; Fig. 34 is a sectional view taken along lines 34 - 34 of Fig. 26; 30 Fig. 35 is a sectional view taken along lines 35 - 35 of Fig. 29; Fig. 36 is a sectional view taken along lines 36 - 36 of Fig. 29; 13 Fig. 37 is an elevational view of the second alternate embodiment of the apparatus of the present invention illustrating the cap and set screw separated from the insert and tray portions thereof; Fig. 38 is a partial sectional elevational view of the second alternate 5 embodiment of the apparatus of the present invention illustrating the mobile insert moving with respect to the tray; Fig. 39 is a perspective exploded view of a third alternate embodiment of the apparatus of the present invention; Fig. 40 is a partial top view of the third alternate embodiment of the 10 apparatus of the present invention illustrating the insert portion thereof; Fig. 41 is a side view of the insert portion of the third alternate embodiment of the apparatus of the present invention; Fig. 42 is a perspective view of the insert portion of the third alternate embodiment of the apparatus of the present invention; 15 Fig. 43 is a posterior view of the insert portion of the third alternate embodiment of the apparatus of the present invention; Fig. 44 is a bottom view of the tray portion of the third alternate embodiment of the apparatus of the present invention; Fig. 45 is a side view of the tray portion of the third alternate 20 embodiment of the apparatus of the present invention; Fig. 46 is a perspective view of the tray portion of the third alternate embodiment of the apparatus of the present invention; Fig. 47 is a posterior view of the tray portion of the third alternate embodiment of the apparatus of the present invention; 25 Figs. 48 - 49 are fragmentary views of the third alternate embodiment of the apparatus of the present invention illustrating one of the plug portions thereof; Figs. 50 -51 are side and top views of a second plug portion that is used with the third alternate embodiment of the apparatus of the present 30 invention; Fig. 52 is a perspective, exploded view of a fourth alternative embodiment of the apparatus of the present invention; 14 Fig. 53 is a sectional, elevational view of the fourth alternative embodiment shown in Fig. 52, shown with the locking member removed; Fig. 54 is another sectional, elevational view of the fourth alternative embodiment shown in Fig. 52, illustrating the locking member in operating 5 position when only rotational movement is desired; Fig. 55 is a partial top view of the fourth alternative embodiment of the apparatus shown in Fig. 52 illustrating the tray; Fig. 56 is a sectional view of the fourth alternative embodiment of the apparatus shown in Fig. 52 taken along lines 56 - 56 of Fig. 55; 10 Fig. 57 is a perspective view of a fifth alternate embodiment of the apparatus of the present invention; Fig. 58 is a side, elevational view of a fifth alternate embodiment of the apparatus of the present invention; Fig. 59 is a posterior elevation view of a fifth alternate embodiment of 15 the apparatus of the present invention; Fig. 60 is a side elevation view of a fifth alternate embodiment of the apparatus of the present invention showing the knee in an extended position; Fig. 61 is a side elevation view of a fifth alternate embodiment of the 20 apparatus of the present invention showing the knee in a flexed position; Fig. 62 is a fragmentary anterior elevation view of a fifth alternate embodiment of the apparatus of the present invention showing polymeric insert; Fig. 63 is a fragmentary posterior elevation view of a fifth alternate 25 embodiment of the apparatus of the present invention showing polymeric insert; Fig. 64 is a fragmentary side sectional elevation view of a fifth alternate embodiment of the apparatus of the present invention showing polymeric insert; 30 Fig. 65 is a fragmentary plan view of a fifth alternate embodiment of the apparatus of the present invention showing polymeric insert; 15 Fig. 66 is a fragmentary bottom view of a fifth alternate embodiment of the apparatus of the present invention showing polymeric insert; Fig. 67 is a fragmentary perspective view of a fifth alternate embodiment of the apparatus of the present invention showing polymeric 5 insert; Fig. 68 is a top view of the fifth alternate embodiment of the apparatus of the present invention; Fig. 69 is a top view of the sixth alternate embodiment of the apparatus of the present invention; 10 Fig. 70 is a fragmentary bottom view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert portions; Fig. 71 is a fragmentary top view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert 15 portions; Fig. 72 is a fragmentary frontal elevation view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert portions; Fig. 73 is a fragmentary rear elevation view of the sixth alternate 20 embodiment of the apparatus of the present invention showing one of the polymeric insert portions; Fig. 74 is a fragmentary side sectional elevation view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert portions; 25 Fig. 75 is a fragmentary perspective view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert portions; Fig. 76 is a side elevation view of the sixth alternate embodiment of the apparatus of the present invention illustrating one of the polymeric 30 insert portions; 16 Fig. 77 is a fragmentary rear elevation view of the sixth alternate embodiment of the apparatus of the present invention illustrating one of the polymeric insert portions; Fig. 78 is a fragmentary bottom elevation view of the sixth alternate 5 embodiment of the apparatus of the present invention illustrating one of the polymeric insert portions; Fig. 79 is a fragmentary frontal elevation view of the sixth alternate embodiment of the apparatus of the present invention illustrating one of the polymeric insert portions; 10 Fig. 80 is a fragmentary plan view of the sixth alternate embodiment of the apparatus of the present invention illustrating one of the polymeric insert portions; Fig. 81 is a fragmentary perspective view of the sixth alternate embodiment of the apparatus of the present invention illustrating one of the 15 polymeric insert portions; Figs. 1 -7 show generally the preferred embodiment of the apparatus of the present invention designated generally by the numeral 10 in Figs. 1, 6 and 7. 20 Mobile bearing knee prosthesis (10) is placed upon a patient's surgically cut proximal tibia (11) at a surgically cut proximal surface (12) that is preferably flat. This enables a tray (13) to be mounted to the proximal tibia (11) at surface (12) as shown in Figs. 6 - 7. Tray (13) has a 25 flat proximal surface (14) and a generally flat distal surface (15) that mates with and faces the surgically prepared surface (12) as shown in Figs. 6 - 7. The tray (13) can provide a plurality of spikes (16) and a stem (17) for enhancing implantation to the patient's proximal tibia (11). However, any other known attachment can be used to affix tray (13) to a patient's 30 proximal tibia such as chemical (e.g. element) or mechanical fasteners (fastener).

17 The proximal surface (14) of tray (13) provides a post (18) having an internally threaded socket (19). Post (18) is comprised of a generally cylindrically-shaped smaller diameter section (20) and an enlarged flange (21) that mounts to the top of cylindrically-shaped (20) as shown in Figs. 5 5 and 13-14. Tray (13) has periphery (22). A recess (23) is provided in between the proximal surface (14) of tray (13) and flange (21). A locking member (24) forms a removable connection with the socket (19). Locking member (24) has an externally cylindrical section (25) that 10 provides threads that correspond to the threads of internally threaded socket (19) so that the locking member (24) can be threaded into the socket (19) as shown in Fig. 7. Locking member (24) includes an enlarged cylindrically-shaped head (26) having a tool receptive socket (27) such as a hexagonal socket for example. 15 An insert (28) provides a vertical channel (33) that can be placed in communication with post (18) as shown in Figs. 6 - 7. Insert (28) provides a preferably flat distal surface (29) that communicates with the flat proximal surface (14) of tray (13). A pair of spaced apart concavities (30, 31) are 20 provided for defining articulation surfaces that cooperate with correspondingly shaped articulating surface on a patient's femur or femoral implant. The insert (28) has a periphery (32) that generally corresponds in shape to the periphery (22) of tray (13). Insert (28) can be polymeric or metallic or of a composite construction, such as metallic with a polymeric 25 articulating surface(s) or polymeric with a metallic articulating surface(s). Vertical channel (33) is comprised of a number of sections that are specially shaped to interact with the post (18) and locking member (24). Vertical channel (33) thus includes a proximal, cylindrically-shaped section 30 (34), an oval shaped slot (35), and a distal opening (36). The distal opening (36) includes a generally oval section (37) and a somewhat half oval section (38). The oval section (38) can track any of three directions C:\NRPortbJ\DCC\TXB\4776067_1.DOC - 29/11/12 -18 including a pure anterior to posterior direction, a direction that is at an angle to a pure anterior to posterior direction; or a direction that is an arcuate or curved path that pivots or rates about a point that is not located along the A/P centreline of the insert. Flat surfaces (39, 40) are positioned at the top 5 of and at the bottom of the oval shaped slot (35) as best seen in Figs 8 11. The cylindrically-shaped head (26) of locking member (24) closely fits the cylindrically-shaped section (36). In order to assemble insert (28) to tray (13), the distal surface of (29) of insert (28) is placed next to and generally parallel to the proximal surface 10 (14) of tray (13). Post (18) is aligned with vertical channel (33) of insert (28). During assembly of insert (28) to tray (13), the post (18) is shaped to enter the oval opening portion (37) of distal opening (36). Once the distal surface (29) of insert (28) meets proximal surface (14) of tray (13), flange (21) aligns with oval shaped slot (35) of vertical channel (33). After such 15 assembly, insert (28) is held in position by post (18). This retention of insert (28) by post (18) occurs when flange (21) engages flat surface (40) to prevent separation if any rotation (see arrow (41) of Fig. 17) at all occurs between insert (28) and tray (13). If no rotation has occurred between insert (28) and tray (13) (see Fig. 15), the oval shaped circular section (37) 20 is sized to allow post (18) to be inserted into or withdrawn from channel (33). In Fig. 15, the apparatus (10) is shown in an assembled position wherein the fastener (24) has been removed so that the insert (28) can move in a translation and rotation and rotation fashion relative to tray (13). 25 In Fig. 16, the fastener (24) has been threadably attached to the internally threaded socket (19) and is in operating position. In Fig. 17, the insert (28) can rotate relative to the tray (13) through an angle (41). However, because of the attachment of fastener (24), only rotation and not translation is permitted in Fig. 17. Thus, in Fig. 17, the apparatus (10) 30 provides a mating mechanism between post (18) and the fastener 19 (24) and the insert (28) that defines a constraining mechanism so that the insert (28) may be constrained for rotation only relative to the tray (13). In Figs. 18 - 21 and 22 - 25, there is seen various alternate 5 constructions of the post that can be used instead of post 18 when the selected post is fitted to the tibial tray (13). In Figs. 22 - 25, an alternate construction of the insert (28) is shown with an illustration of the various types of relative motion between the insert and the tibial tray that can be selectively provided to a surgeon. 10 In Figs. 18 - 21, four different constructions of the post are provided. In Fig. 18, a post (42) has a cylindrical outer surface (43) and a circular top (44). Post (42) has a rectangular base (45) with a generally flat undersurface and a plurality of four inclined surfaces (46) which provides a 15 means of attaching the post to the tray or the post may be permanently attached to the tray. The rectangular base (45) fits tray (13A) socket (47) at its inclied surfaces (48) with a taper lock type connection for example. Other types of connections could be used to join post (42) to tray (13A) at socket (47). 20 In Fig. 19, post (49) includes a plurality of four vertical side walls (50) and a plurality of inclined surfaces (51). A rectangular flat top (52) is provided opposite a generally flat undersurface of post (49). The inclined surfaces (51) of post (49) fit similarly configured inclined surfaces (48) of 25 socket (47) in tray (13A). In Fig. 20, post (53) is generally rectangularly shaped providing a pair of opposed flat larger vertical side walls (54) and a pair of opposed flat smaller end walls (55) with a flat top (56). Post (53) has a base (57) that 30 includes four inclined surfaces (58). The inclined surfaces (58) form a taper lock connection with four similarly configured inclined surfaces (48) of socket (47) of tray (1 3A).

20 In Fig. 21, post (59) has a hexagonal shape providing a hexagonally shaped flat top (60). Hexagonal post (59) also has a plurality of vertical side walls (61) and a rectangular base (62). The base (62) has inclined 5 surfaces (63) that form a taper lock connection with inclined surfaces (48) of tray socket (47) of tray (1 3A). In Fig. 22, insert (28A) provides a square opening (64) that exactly fits peg (49). In Fig. 22, there is no relative motion between insert (28A) and 10 tray (13A). In Fig. 23, rotational motion only is indicated by arrow (65) between insert (28A) and tray (13A) when peg (42) is used. In Fig. 24, the rectangular peg (53) enables only translational movement between the insert (28A) and tray (13A) as indicated by arrow 15 (66). In Fig. 25, the hexagonal peg (59) enables both rotational motion as indicated by arrow (65) and translational motion as indicated by arrow (66) between insert (28A) and tray (13A). An alternate embodiment of mobile bearing knee apparatus (110) is 20 shown generally in Fig. 37. In Fig. 37, the prosthesis (110) is shown positioned upon a patient's proximal tibia (111), specifically upon a flat surgically cut proximal surface (112) as shown. In Figs. 26 - 28, tibial tray (113) is shown, which can be of metallic 25 construction such as titanium alloy, for example. Tray (113) has a flat proximal surface (114) and a flat distal surface (115). A plurality of mechanical fasteners such as spikes (116) on surface (115) can be used to enhance fixation of tibial tray (113) to the patient's proximal tibial (111). Chemical fasteners (e.g. cement) can also be used for fixation. A stem 30 (117) can also be used to facilitate attachment of prosthesis (110) to the patient's tibia (111) at the tibial intramedually canal.

C:\NRPortbnDCC\TXB\4776067_1 DOC - 29/11112 - 21 The flat proximal surface (114) of tray (113) has a round post (118) with a hollow bore or socket (119). The post (118) is spaced inwardly from the periphery (120) of tray (113) as shown in Figs. 26 - 27. The post (118) is preferably positioned with an offset with respect to oval slot (126) in the 5 articular insert to provide anterior stabilization in the total knee prosthesis. Figs. 29 - 31 show the insert (121) portion of the apparatus, typically a polymeric plastic insert that fits tray (113). Insert (121) has a flat distal surface (122) and a proximal surface (123) that includes curved portions. These curved portions are in the form of concavities (124, 125) receive 10 shaped surfaces of a femoral prosthesis after total knee replacement surgery is completed. The flat distal surface (122) of insert (121) has an anterior to posterior extending generally oval shaped slot (126) as shown in Fig. 31. The slot (126) receives post (118) during use, enabling the insert 15 (121) to slide in an anterior to posterior direction relative to tray (113). The apparatus comprises a rotating platform, mobile knee prosthesis (110) that incorporates anterior stabilization along with the ability to selectively constrain the movement of the articular surface from rotation and translation to rotation only. This is accomplished by using an opening 20 (136) in insert (121) that communicates with slot (126) as shown in Figs. 29 -31 and 35 - 38. The opening includes a frustoconical portion (137) that corresponds in shape to a similar frustoconically-shaped enlarged annular surface (134) of locking plug member (127). The locking plug member (127) is shown more particularly in Figs. 32 - 33 and 37. 25 Locking plug member (127) includes a lower frustoconical surface (128). The frustoconical outer surface (128) of locking member (127) below annular reference line (138) is sized and shaped to fit and form a taper lock connection with surface (139) of frustoconical socket (119) of post (118). Above annular reference line (138), the enlarged annular shoulder has a 30 frustoconical shape as shown in Fig. 32 that corresponds generally to the - 22 size and shape of frustoconical portion (137) of opening (136) as shown in Fig. 36. When the locking member (127) is first placed through opening (136) of insert (121) and then into frustoconical socket (119) of post (118), a 5 locking connection is formed between the frustoconical outer surface (128) of locking member (127) and the frustoconical surface (139) of post (118). This connection can be a taper lock type connection. Locking screw (131) can be used to engage a correspondingly sized and shaped internally threaded opening (132) of tray (113) if desired. The 10 locking screw (131) can include a head (140) that is enlarged so that the head (140) is retained by annular shoulder (133) of locking member (137) as shown in Figs. 33 and 37. In Fig. 38, arrows (141) indicate sliding movement of insert (121) relative to tray (113) as occurs when locking plug member (127) is 15 removed. In such a situation, the insert (121) is free with respect to tray (113). The distal surface (122) of insert (121) slides upon the flat proximal surface (114) of tray (113). Post (118) slides relative to slot (126). When locking member (127) is inserted through opening (136) and into socket (119) of post (118), sliding movement is prevented. The 20 enlarged annular (134) of locking member (127) engages the frustoconical portion (137) of opening (136) disallowing a sliding action of insert (121) relative to tray (113). However, the enlarged annular shoulder (134) of locking member (127) is slightly spaced from frustoconical portion (137) of opening (136), so that rotational movement of insert (121) relative to tray 25 (113) is permitted. A second alternate embodiment provides a rotating platform, mobile knee prosthesis (110) that incorporates anterior stabilization along with the ability to constrain movement of the articular surface from rotation and translation to rotation only.

- 23 Figs. 39 and 40 - 51 show a third alternate embodiment of the apparatus designated generally by the numeral 142 in Fig. 39. Mobile bearing knee prosthesis (142) includes a tray (143) that can be attached to a patient's surgically cut proximal tibia using a stem (146) for example that 5 occupies the patient's intramedullary canal. The tray (143) has a proximal surface (144) that receives an insert (159) and a distal surface (145) that registers upon the proximal tibia after the tibia has been surgically prepared to conform to the underside or distal surface (145) of tray (143). The proximal (144) surface of tray (143) provides a frustoconically 10 shaped socket (147) that can receive either of two selected plugs (148 or 154) (or any of the plug embodiments shown in Figs. 18 - 21). The first plug (148) is designed to provide rotational movement only between insert (159) and tray (143). The plug (148) has a frustoconical surface (149), cylindrical surface (150), bevelled annular surface (151), and a pair of 15 opposed generally parallel flat end surfaces (152, 153). The second plug (154) is designed to provide both anterior to posterior translational movement between the insert (159) and tray (153) as well as rotational movement between the insert (159) and tray (153). The plug (154) has a frustoconical surface (155), a reduced diameter cylindrical 20 surface (156), and flat end surfaces (157, 158). During use, a surgeon selects either of the plugs (148 or 154). The frustoconical surfaces (149 or 155) form a tight taper lock fit with a correspondingly shaped frustoconical socket (147) that communicates with the proximal (144) surface of tray (143). Once the selected plug (148 or 24 154) has been inserted into frustoconical socket (147), the insert (159) is placed on the selected plug (148 or 154). The shape of the plug (148 or 154) that is selected determines whether or not the insert (159) can achieve only rotational movement relative to tray (143) or both rotational and 5 anterior to posterior translational movement. In the case of the plug (148), only rotational movement between the insert (159) and the tray (143) can be attained. The plug (148) is shorter and thus only communicates with the cylindrically-shaped opening (164) on 10 the bottom or distal surface (162) of insert (159). Plug (148) once inserted in socket (147) only enables a rotational movement of the insert (159) on the tray (143). The cylindrical surface (150) of plug (148) corresponds in size and shape to the circular opening (164) to accomplish a relatively close fit between cylindrical surface (150) of plug (148) and cylindrical opening 15 (164) on insert (159). When both rotational and translational anterior to posterior movement are desired, the surgeon selects the plug (154). The plug (154) is placed in socket (147) so that frustoconical surface (155) forms a taper lock fit with a 20 correspondingly sized and shaped socket (147) of tray (143). The smaller cylindrically-shaped portion (156) of plug (154) is taller in a proximal to distal direction than the cylindrically-shape portion (150) of plug (148). The portion (156) fits elongated slot (163) so that the insert (159) can translate in an anterior to posterior direction as the reduced diameter cylindrical 25 portion (156) travels anterior to posterior in the direction of arrow (165) in Fig. 44. However, the insert can also translate along the path (165) that curved, or along a path (165) that forms an angle with a purely anterior to posterior direction line. The line (165) in Fig. 44 shows such a purely anterior to posterior line as the direction of travel. Because the slot (163) is 30 at least as wide as the diameter of cylindrical portion (156) and tray (143). Insert (159) also provides proximal concavities (160, 161) for receiving a femoral component of a knee implant.

C:NRPortbl\DCC\TX8\4776067_1.DOC - 29/11/12 - 25 Figs. 52 - 56 disclose a fourth alternate embodiment of the apparatus identified as prosthesis (210), comprising a tibial tray (213), a polymeric insert (28), and a locking member (24). In this embodiment, insert (28) and locking member (24) are the same as described above, but flange (221) is 5 generally D-shaped, having a periphery extending laterally in the medial, lateral, and anterior directions from the out surface of cylindrical section (220), thereby creating recess (223) on the medial, lateral and anterior sides of section (220) (see Figs. 55 - 56). As evidenced by the following description, the assembly of prosthesis (210) is essentially identical to that 10 of prosthesis (10) except for the shape of flange (221). Locking member (24) forms a removable connection with the socket (219). Locking member (24) has an externally cylindrical section (25) that provides threads that correspond to the threads of internally socket (219) so that the locking member (24) can be threaded into the socket (219) as 15 shown in Fig. 54. In order to assemble insert (28) to tray (213), the distal surface (29) of insert (28) is placed next to and generally parallel to the proximal surface (214) of tray (213). Post (218) is aligned with vertical channel (33) of insert (28). During assembly of insert (28) to tray (213), the post (218) is oriented 20 to enter the oval opening portion (37) of distal opening (36). Once the distal surface (29) of insert (28) meets proximal surface (214) of tray (213), flange (221) aligns with oval shaped slot (35) of vertical channel (33). After such assembly, insert (28) is held in position by post (218). This retention of insert (228) by post (218) occurs when flange (221) engages flat surface 25 (40) to prevent separation if any rotation at all occurs between insert (28) and tray (213). If no rotation has occurred between insert (28) and tray (213), the oval shaped circular section (37) is sized to allow post (218) to be inserted into or withdrawn from channel (33).

- 26 Figs. 57 - 67 show a fifth alternate embodiment of the apparatus designated generally by the numeral 200 in Figs. 57 - 61. It should be understood that the embodiment of Figs. 57 - 61 disclose an alternate construction for a polymeric insert (202) that interconnects with the same 5 tibial tray (13) and stem (17) shown in Figs. 1, 5 - 7 and 14 - 16 of the preferred embodiment. In Figs. 57 - 59, mobile bearing knee prosthesis (200) is shown as including tray (13), polymeric insert (202), and femoral component (236). In Fig. 58, the femoral component (236) is shown attached to a patient's surgically cut distal demur (201). 10 Polymeric insert (202) (see Figs. 62-67) has a flat distal surface (203) and a proximal surface with a pair of concavities (204, 205). Insert (202) also has periphery (206) and vertical channel (207). The vertical channel (207) can be a slotted arrangement such as that shown in the preferred embodiment of Figs. 1 - 17 and designated generally by the numeral 33. 15 Thus, the connection between post (18) of tray (13) and insert (202) can be the same connection that is shown and described with respect to the preferred embodiment of Figs. 1 -17 and shown particularly in Figs. 1 - 7 and 15 - 17, or as shown in Figs. 52 -56. Vertical channel (207) can include a proximal cylindrically-shaped 20 section (208), an oval shaped slot (209), and a distal opening (224). The distal opening (224) can include an oval section (226) and a half oval section (227) as shown in Fig. 66. Flat surface (225) extends posteriorly of vertical channel (207) more particularly posteriorly of the proximal cylindrically-shaped section (208), as shown in Figs. 64 - 65. Flat surfaces 25 (228, 229) register with the flange (21) of post (18), respectively above and below the flange (21) to thereby prevent separation of polymeric insert (202) from post (18) unless the post (18) is aligned with oval section (226) of distal opening (224). When the flange (21) of post (18) aligns with oval section (226) of distal opening (224), insert (202) can be separated from 30 tray (13).

27 In the embodiment of Figs. 57 - 68, insert (202) provides a central post (230). Post (230) has proximal surface (231), anterior surface (232), posterior surface (233), and sides (234, 235). 5 Femoral component (236) is shown in Figs. 57 -61. Femoral component (236) has anterior portion (237), a pair of posterior condylar portions (238, 239) and distal condylar portions (240, 241). Femoral component (236) has central opening (242) and a horizontal bar cam (243) 10 that extends between posterior condylar portions (238, 239) as best seen in Figs. 59 and 68. A pair of vertical walls (244, 245) extend along opposing sides of central opening (242) and connect to both of the posterior condylar portions (238, 239) and to horizontal bar (243). The vertical walls (230, 231) also extend to and connect to surfaces (248, 249, 250). The vertical 15 walls (244, 245) can be generally parallel. Femoral component (236) provides a plurality of flat surfaces that register against and conform to surgically cut flat surfaces that are provided on the patient's distal femur (201) as shown in Fig. 58. These flat surfaces 20 include flat surface (246) is an anterior surface, surface (247) which is a diagonally extending anterior surface that spans between anterior surface (246) and distal surface (248). Distal surface (248) spans between diagonal surface (247) and posterior diagonal surface (249). Posterior surface (250) is generally parallel to anterior flat surface (246). These five 25 flat surfaces (246 - 250) of femoral component (236) register against and conform to five surgically cut surfaces on a patient's distal femur (201). Femoral component (236) can be securely fashioned to the patient's femur (201) using bone cement for example. 30 In Figs. 60 - 61, a range of motion for the patient's knee fitted with mobile bearing knee prosthesis (200) as illustrated with arrows (252, 253). For purpose of reference, the patient's central longitudinal axis (251) of the C:1NRPortbl\DCC\TXB\4776067_1. DOC - 29/11/12 - 28 distal femur (201) is shown rotating posteriorly in the direction of arrow (253). The anterior surface (237) of femoral component (236) is shown rotating in the direction of arrow (252). Fig. 60 shows an extended position of the patient's knee wherein the longitudinal axis (251) of the femur (201) 5 is generally aligned with the central longitudinal axis of the patient's tibia (11). In Fig. 61, the knee is shown in a flexed position. In this position, horizontal bar cam (243) of femoral component (222) registers against the posterior surface (233) of central post (230) of polymeric insert (202). In this position, the central post (230) causes femoral roll back on the tibia 10 articular insert (202). The posterior aspect of the tibia articular surface at (233) provides a lift that is created by generally following the curvature of the femoral component (236) in extension. This will provide a high degree of surface contact, conformity, subsequently providing low contact stress, in extension, where most of gait occurs. The post (230) can have a square or 15 rectangular base that fits snugly within the central opening (242) of the femoral component (236). By providing the posterior stabilized design with the central post (230), as the knee is flexed, the horizontal bar cam (243) acts as a cam on the femoral component (236) to engage the post (230) at surface (233) on the 20 tibial component (202), causing the femoral posterior condyles (238, 239) to roll back onto the tibial articular concavity surfaces (204, 205). This "roll back" coupled with "climbing" the posterior aspect of the tibial articular surface at (233), causes the femoral component (236) to be located out of the lowest aspect of the tibial articular surfaces (204, 205). With this 25 condition, any type of varus/valgus loading of the joint will cause one of the femoral condyles to apply higher downward loads than the opposing condyle. With a differential in loads, the tibial component (202) will freely spin until the higher loaded condyle displaces to the low point of the tibial articular surface. The central tibial post (230) forces the opposite condyle 30 out of the posterior aspect of the tibial articular surface, thus creating a spin out.

C:\NRPortbl\DCC\TXB\4776067_1. DOC - 29/11/12 - 29 The apparatus allows for a free, unlimited rotation of the tibial insert (202) relative to its baseplate (13). All of the rotational constraints occurs between the femoral component (236) and the insert (202). The apparatus builds conformity of the central post (230) of the insert (202) relative to the 5 box of the femur in rotation, but allowing for varus/valgus tilting. The central insert post (230) is generally trapezoidal. A sixth alternate embodiment of the apparatus is shown in Figs. 69 81. In the embodiment of Figs. 69 -81, a mobile bearing knee prosthesis (254) features a two-part polymeric insert that includes first member (255) 10 shown in Figs. 69 -75 and a second member (264) shown in Figs. 69 and 76 - 81. Polymeric insert (255) (see Figs. 70 - 75) has a central opening (256) that is bordered by a pair of spaced apart, generally parallel shoulders (257, 258) upon which second member (264) slides fore and aft. The insert (255) has a periphery (259) a proximal surface with a pair of 15 concavities (260, 261). The insert member (255) includes a flat distal surface (262). The second insert member (264) has a proximal surface (265), a distal surface (267) and a passageway (263) that extends between the surfaces (265, 267). A pair of spaced apart, generally parallel shoulders (268, 269) 20 are provided on opposing sides of insert (264) as shown in Figs. 77, 79 and 81. Flat surfaces (270, 271) are also provided on opposing sides of insert member (264). The surface (270) is generally perpendicular to shoulder (268). The surface (277) is generally perpendicular to the shoulder (267) as shown in Fig. 79. 25 Insert member (264) provides a post (272). Post (272) has flat, proximal surface (273), anterior surface (274), posterior surface (275), and sides (276, 277). The member (264) provides a curved anterior surface (278) that is correspondingly shaped to and fits against the correspondingly shaped concave surface (279) of member (255) at opening (256).

- 30 During use, the shoulders (268, 269) of insert member (264) fit against and slide upon the shoulders (257, 258) of insert member (255). Flat surfaces (270, 271) of insert member (264) engage and slide against flat surfaces (280, 281) of insert (255). The insert member (264) slides upon 5 the insert member (255) in an anterior to posterior direction because the opening (256) is longer than the insert member (264). The opening (256) is larger in an anterior to posterior direction than the length of the insert member (264) measured from an anterior to posterior direction such as between surfaces (278) and (280). 10 The apparatus includes a posterior stabilizing post (272) secured to the central insert member (264). The posterior stabilized post (272) captures or is captured by bearing insert component (255) to the tibial baseplate (13) through an elongated slot or opening (256) in the bearing component (255). The elongated opening or slot (256) in the bearing 15 component member (255) allows it to translate anteriorly and posteriorly with respect to the posterior stabilized post (272) of the insert member (264). The bearing component (255) may also rotate with respect to the tibial baseplate (13) in conjunction with the posterior stabilized post (272). The bearing component (255) has two concave surfaces (260, 261) 20 that are configured to articulate with the convex surfaces [condylar portions](240, 241) of the femoral component (236) at full extension. The posterior stabilized post (272) articulates with a horizontal bar cam (243) of the femoral component (236) to provide femoral roll back. The bearing design thus consists of a bearing articular insert (255) 25 with a separate posterior stabilized post component (264) that may have one or more degrees of freedom. The bearing articular 31 insert (251) has two concave surfaces (260, 261) that articulate with the convex surfaces [condylar portions](240, 241) of the femoral component (236) at full extension. The posterior stabilized post (272) articulates with a recess or cam (243) of the femoral component (236) to provide femoral roll 5 back. The rotational freedom of the posterior stabilized post (272) maintains contact with the femoral bar cam (243) during external or internal rotation of femoral component (236). The posterior stabilized member (255) has a flat distal surface (262) 10 that articulates with the tibial baseplate (13). A tee slot (266) is located n the distal surface (267) and articulates with a tee post (18) on the tibial baseplate (13) (see Figs. 1 -17 for such a tee slot and tee post connection). A through hole (263) in the component (264) is located such that a rotation peg (such as peg (24) in Figs. 1 - 7) can capture the component (264) to 15 the tibial baseplate (13) while the tee slot of the insert component (264) is engaged with a tee post (18) of the tibial baseplate. Rotation peg (24) allows only rotational freedom of the insert component (264) with respect to the tibial baseplate (13). The elongated slot (256) of the bearing component (255) is larger than the posterior stabilized post carrying 20 component (255) in the anterior-posterior direction such that the bearing component has limited translation with respect to the posterior stabilized post. The bearing component (255) may also rotate with respect to the tibial baseplate (13) in conjunction with posterior stabilized post component (264). 25 Horizontal bar cam mechanism (243) on the femoral component (236) is preferably a concavely shaped cylinder as shown in Figs. 59 and 68, that registers against and engages the convex posterior surface (275) of the posterior stabilized post (272). The internal/external rotation of the 30 posterior stabilized post component (264) with the femoral component (236) maintains this contact throughout the range of motion.

C:NRPortbl\DCC\TXB\4776067_1. DOC - 29/11/12 - 32 As an alternate construction, the second (central) insert member (264) could rotate only with respect to the tibial prosthesis, and the first (peripheral) insert member could both rotate and translate with respect to the tray. 5 PARTS LIST The following is a list of suitable parts and materials for the various elements of the preferred embodiments of the present invention. Part Number Description 10 mobile bearing knee prosthesis 11 tibia 12 surgically cut proximal surface 13 tray 13A tray 14 flat proximal surface 15 flat distal surface 16 spike 17 stem 18 post 19 internally threaded socket 20 cylindrically-shaped section 21 flange 22 periphery 23 recess 24 fastener 25 externally threaded section 26 head 27 tool receptive socket 28 insert 29 flat distal surface 30 concavity 31 concavity 32 periphery 33 vertical channel 34 proximal, cylindrically-shaped section 35 oval shaped slot 36 distal opening 37 oval section 33 38 half oval section 39 flat surface 40 flat surface 41 arrow/angle 42 post 43 cylindrical surface 44 circular top 45 rectangular base 46 inclined side wall 47 tray socket 48 inclined surface 49 post 50 vertical side wall 51 inclined surface 52 flat top 53 post 54 vertical side wall 55 vertical end wall 56 flat top 57 rectangular base 58 inclined surface 59 post 60 flat top 61 vertical side wall 62 rectangular base 63 inclined surface 64 insert opening 65 arrow 66 arrow 110 mobile bearing knee prosthesis 111 tibia 112 surgically cut proximal surface 113 tray 114 flat proximal surface 114A opening 115 flat distal surface 116 spike 117 stem 118 post 119 socket 120 periphery of tray 121 insert 122 flat distal surface 123 proximal surface 34 124 concavity 125 concavity 126 slot 127 locking plug member 128 frustoconical outer surface 129 socket 130 threaded bore 131 locking screw 132 internally threaded opening 133 annular shoulder 134 enlarged annular shoulder 135 periphery of insert 136 opening 137 frustoconical portion 138 annular reference line 139 frustoconical surface 140 enlarged head 141 arrows 142 mobile bearing knee prosthesis 143 tray 144 proximal surface 145 distal surface 146 stem 147 frustoconical socket 148 plug 149 frustoconical surface 150 cylindrical surface 151 bevelled annular surface 152 flat end surface 153 flat end surface 154 plug 155 frustoconical surface 156 reduced diameter cylindrical surface 157 flat end surface 158 flat end surface 159 insert 160 proximal concavity 161 proximal concavity 162 flat distal surface 163 elongated slot 164 cylindrical opening 165 arrow 200 mobile bearing knee prosthesis 201 surgically cut femur 35 202 polymeric insert 203 flat distal surface 204 concavity 205 concavity 206 periphery 207 vertical channel 208 proximal cylindrically-shaped section 209 oval shaped slot 210 mobile bearing knee prosthesis 213 tray 214 flat proximal surface 215 flat distal surface 216 spike 217 stem 218 post 219 internally threaded socket 220 cylindrically-shaped section 221 flange 222 periphery 223 recess 224 distal opening 225 flat surface 226 oval section 227 half oval section 228 flat surface 229 flat surface 230 central post 231 proximal surface 232 anterior surface 233 posterior surface 234 side 235 side 236 femoral component 237 anterior portion 238 posterior condylar portion 239 posterior condylar portion 240 distal condylar portion 241 distal condylar portion 242 central opening 243 horizontal bar cam 244 vertical wall 245 vertical wall 246 flat surface 247 flat surface 36 248 flat surface 249 flat surface 250 flat surface 251 central longitudinal axis 252 arrow 253 arrow 254 mobile bearing knee prosthesis 255 polymeric insert bearing component 256 central opening 257 shoulder 258 shoulder 259 periphery 260 concavity 261 concavity 262 distal surface 263 through hole 264 central insert component 265 proximal surface 266 tee slot 267 distal surface 268 shoulder 269 shoulder 270 flat surface 271 flat surface 272 post 273 flat proximal surface 274 anterior surface of post 275 posterior surface of post 276 side 277 side 278 curved anterior surface 279 concave surface 280 posterior surface 281 flat surface 282 flat surface The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.

C:\NRPortbl\DCC\TXB\47760671. DOC - 29/11/12 - 37 The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of 5 suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates. Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as 10 "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

Claims (25)

1. 2. A knee prosthesis of claim 1 wherein the constraining mechanism includes a post extending up from a proximal surface of the tibial insert.
2. 3. A knee prosthesis of claim 2 wherein the femoral component includes an intercondylar surface that is positioned to contact the post, - 39 enabling relative motion between the femoral component and the tibial insert to be constrained.
3. 4. A knee prosthesis of claim 1 wherein the central member slidably connects to the peripheral member.
4. 5. A knee prosthesis of claim 1 wherein the central member connects to the tibial tray portion and the peripheral member connects to the central member.
5. 6. A knee prosthesis of claim 1 wherein a proximal surface of the tibial insert has one or more concavities for articulating with the femoral component.
6. 7. A knee prosthesis of claim 6 wherein there are two concavities that define the articulation surface.
7. 8. A knee prosthesis of claim 1 wherein the constraining mechanism includes a post extending up from a proximal surface of the tibial tray portion.
8. 9. A knee prosthesis of claim 8 wherein the central member connects to the post.
9. 10. A knee prosthesis of claim 2, 3, 8 or 9 wherein the post has a socket and the constraining mechanism includes a locking plug member that is connectable to the socket on the post.
10. 11. A knee prosthesis of claim 1 wherein the constraining mechanism includes a post extending up from a proximal surface of the tibial tray portion, a slot on a distal surface of the tibial insert, an opening on a proximal surface of the tibial insert that communicates with the slot and a locking plug member that can access and connect to the post from the proximal surface of the tibial insert via the opening. - 40
11. 12. A knee prosthesis of claim 11 wherein the femoral component includes an intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral component and the tibial insert to be constrained.
12. 13. A knee prosthesis of claim 11 or 12 wherein the constraining mechanism includes a socket on the post that receives the locking plug member, wherein the locking plug member is attached to the post for further defining movement between the tibial insert and tibial tray portion.
13. 14. A knee prosthesis of any one of claims 11 to 13 wherein the opening is defined by an annular surface that fits closely to the locking plug member when the locking plug member is connected to the post.
14. 15. A knee prosthesis of claim 1 wherein the constraining mechanism includes an opening that extends from a proximal to a distal surface of the tibial insert and a variety of connectable portions which are selectively attachable to or separable from the tibial tray porition, and wherein the geometry of the various connectable portions relative to the opening enables a user to determine which of the relative motions will take place.
15. 16. A knee prosthesis of claim 1 further comprising: a. a post mounted at a central portion of a proximal surface of the tibial tray portion, the post having a socket; b. a generally vertical channel at a central portion of the tibial insert that extends through the tibial insert, the channel including an elongated slot portion that extends a partial distance through the tibial insert, beginning at a distal surface of the tibial insert and terminating at a position intermediate a proximal surface of the tibial insert and the distal surface of the tibial insert, the - 41 elongated slot portion extending generally along an anterior to posterior line; c. the elongated slot portion removably connecting to and sliding with respect to the post ; and d. a locking member for selectively locking the tibial insert and tibial tray portion together with a rotational connection, the locking member extending through the tibial insert to connect with the post; wherein e. the tibial insert and tibial tray portion are being configured to enable selected relative motion between them by respectively connecting or disconnecting the locking member, with the tibial insert being rotatable relative to the tibial tray portion when the locking member connects to the post; and f. the first and second connectable members are rotatable relative to the third tray portion when the locking member is assembled with the post.
16. 17. A knee prosthesis of claim 16 wherein the constraining mechanism includes a post extending up from the proximal surface of the tibial insert.
17. 18. A knee prosthesis of claim 17 wherein the femoral component includes an intercondylar surface that is positioned to contact the post extending up from the proximal surface of the tibial insert, enabling relative motion between the femoral component and the tibial insert to be constrained.
18. 19. A knee prosthesis of claim 16 wherein the tibial insert has a post.
19. 20. A knee prosthesis of claim 19 wherein the tibial insert post has a socket that receives the locking member. - 42
20. 21. A knee prosthesis of claim 16 wherein the channel extends through the insert, communicating with both the proximal and distal surfaces of the tibial insert.
21. 22. A knee prosthesis of claim 21 wherein the channel has a larger transverse cross section at the distal surface of the tibial insert and a smaller transverse cross section at the proximal surface of the tibial insert.
22. 23. A knee prosthesis of claim 18 wherein the channel closely conforms to the locking member at the proximal surface of the tibial insert.
23. 24. A knee prosthesis of claim 18 wherein the first and second connectable members are slidably connected during use.
24. 25. A knee prosthesis of claim 1 in which the femoral component articulates with the tibial insert.
25. 26. A knee prosthesis of claim 16 in which the femoral component engages the tibial component.