FR3052047A1 - Implantable medical device for solidarizing bone parts separated for fusion - Google Patents

Implantable medical device for solidarizing bone parts separated for fusion Download PDF

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Publication number
FR3052047A1
FR3052047A1 FR1655023A FR1655023A FR3052047A1 FR 3052047 A1 FR3052047 A1 FR 3052047A1 FR 1655023 A FR1655023 A FR 1655023A FR 1655023 A FR1655023 A FR 1655023A FR 3052047 A1 FR3052047 A1 FR 3052047A1
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FR
France
Prior art keywords
plate
anchoring
device
clip
bone
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
FR1655023A
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French (fr)
Inventor
Cyril Perrier
Ronny Lopes
Maxime Dechelette
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NEOSTEO
Original Assignee
NEOSTEO
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by NEOSTEO filed Critical NEOSTEO
Priority to FR1655023A priority Critical patent/FR3052047A1/en
Publication of FR3052047A1 publication Critical patent/FR3052047A1/en
Application status is Pending legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8004Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with means for extending or compressing the bone or bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0642Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/809Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with bone-penetrating elements, e.g. blades or prongs

Abstract

Implantable medical device (1) for the joining of bone parts (20) separated from one another by a line (21) of fracture, osteotomy or arthrodesis, for fusion of said parts (20) ) bone. This device (1) comprises a plate (2) and at least one staple (3) respectively positionable astride the line (21) of fracture, osteotomy or arthrodesis, the or at least one of the staples, in the general U-shape, comprising two anchoring branches (4) capable of being inserted on either side of the fracture, osteotomy or arthrodesis line (21) and a connecting bridge (5) for said branches (4) anchoring forming the core of the U, said clip (3) being a deformable clip between a closed position, in which the anchoring legs (4) of the clip (3) converge in the direction of the end (41) free anchoring legs (4), and an open position, wherein the legs (4) anchoring the clip (3) extend substantially parallel to each other, the branches (4) ) anchoring the clip (3) elastically deformable and / or shape memory being configured to move from the open position to the closed position by recall éla and / or under the effect of a rise in temperature.

Description

FIELD OF THE INVENTION The invention relates to an implantable medical device for the joining of bone parts separated from each other by a fracture, osteotomy or arthrodesis line, with a view to melting said bone parts. and an assembly comprising at least one piercing template and such a medical device.

PRIOR ART

Bone fusion, that is, the joining of two bones or bone fragments for the union into one, is the goal after fracture of a bone, or after the practice of an osteotomy or osteotomy. an arthrodesis.

To achieve such bone fusion, an implantable medical device is used. The goal of the surgeon is to obtain a good stability, both primary and secondary, in order to obtain the consolidation of the bone parts in the best conditions, that is to say in the position chosen by the surgeon, minimizing the problems of postoperative pain, edema, and shortening as much as possible the time of consolidation.

To obtain this result, the stability of the osteosynthesis related to the implantable medical device is critical. To facilitate consolidation, it is known to design the medical device with a possibility of providing and maintaining a slight compression on the bone parts to be fused.

In the basic version, the compression is obtained using a compression screw. Thus, in the case of a metatarsophalangeal arthrodesis (MTP), for example, said screw is introduced by the medial plantar phalanx and latero-dorsal tip in the metatarsal. Both bones are thus compressed. A locked plate is then placed on the back to secure the bones in position. This screw can also be replaced by a self-compressive screw.

In order to improve the stability of the assembly, this compression screw is sometimes integrated into the plate, generally in an unlocked manner. This results in: - a dorsal thickening of the plate to house the connection system (WO2014084974A1), - a plantar thickening of the plate to house the connection system, which can lead to complex milling in the form of the prominence of the connection system . In addition, according to some embodiments, this system present in the bone structure can be blocked during bone recolonization, making it difficult to remove the system (WO2010037985), -a widening of the plate to relocate the system (EP1897509A1) or (WO2013101979A1). ). a recess of large diameter weakening the plate, since it requires to house the head of the screw. This is the case of the systems described in WO2013085835A1. -There is also in osteosynthesis rack plates (EP2494933A2) too complex and cumbersome for MTP arthrodesis, the thickness of the system must remain of the order of 1.0 mm ideally.

The finding is that no system can achieve a real dynamic compression without crossing the line of arthrodesis or osteosynthesis. Now it is known that this area where the bone fusion must take place must be free of any material that can disturb the consolidation, and which reduces the volume of bone to regenerate. In addition, the use of compression screws is unsuitable for osteoporotic bone, whose affected population is most likely to receive an arthrodesis gesture. Finally, the size of existing implants makes it difficult to use for the bones of the hands and feet. GOALS AND SUMMARY

An object of the invention is to provide an implantable medical device whose design allows to promote bone fusion by inter fragmentary compression, without crossing the fraction line of osteotomy or arthrodesis or fracture.

Another object of the invention is to provide an implantable medical device whose design allows easy installation.

Another object of the invention is to provide an implantable medical device whose design allows immediate recovery of the patient on a highly stressed joint, a reduction of discomfort, under the skin and the boot, in the case of a implantation of the device at the level of the foot, and a decrease in invasiveness, in particular at the length of the incision required for implantation. To this end, the subject of the invention is an implantable medical device for the joining of bone parts separated from one another by a fracture, osteotomy or arthrodesis line, with a view to a fusion of said parts. characterized in that said device comprises a plate and at least one staple respectively positionable straddling the fracture line, osteotomy or arthrodesis, the or at least one of the staples, generally U-shaped, comprising two anchoring branches adapted to be inserted on either side of the fracture, osteotomy or arthrodesis line and a connecting bridge of said anchoring legs forming the core of the U, said staple being a staple deformable between a closed position, in which the anchoring legs of the staple converge towards the free end of the anchoring legs, and an open position, in which the anchoring legs of the staple are extend substantially parallel to each other, the anchoring legs of the elastically deformable clip and / or shape memory being configured to move from the open position to the closed position by elastic return and / or under the effect of a rise in temperature. The assembly formed by the staple and the plate and resulting from the combined use of a staple and a plate separable from one another makes it possible, in parallel with maintaining the compression of the bone parts by the staple immobilizing said bone portions with the aid of the plate, without crossing the arthrodesis or osteotomy fracture line. The possibility of allowing, in parallel with the maintenance in compression of the bone parts, the immobilization of said bone parts with the aid of the plate, facilitates the installation of the plate.

According to one embodiment, the plate comprises at least one orifice, said guide, through which inside an anchor branch of the or staple is adapted to be inserted. With this design, the staple is supported on the plate, to achieve the compression.

According to one embodiment, the plate comprises, on its so-called internal support surface on the bony parts to be fused, at least one anchor pad extending projecting from the internal face and able to fit into the one of the bony parts. This results in ease of installation of the device, in particular the plate of the medical device.

According to one embodiment, the orifice or at least one of the through-guide orifices, inside which an anchoring branch of the staple or staple is able to be inserted, is formed by an obviously anchor pad.

According to one embodiment, the or at least one of the anchoring studs opens into a slot in the plate, said slot serving to insert the connecting bridge of the staple into the thickness of the plate. This results in a reduced thickness of the medical device.

According to one embodiment, the or at least one of the anchor pads is pre-equipped with a socket. This sleeve forms a spacer between the stud and the staple. Thus, any interference between the material constituting the plate and the material constituting the staple can be avoided.

According to one embodiment, the plate is provided with at least two through holes, preferably at least four through holes, each defining a passage for receiving a member, such as a screw, for anchoring the plate said bone parts. The anchoring members may be mono axial or poly axial.

According to one embodiment, the longitudinal axes of at least two of the passages delimited by the through orifices are non-parallel to one another and intersect on the inner side of the plate supporting the bony portions to be fused. This results in better resistance to tearing the plate.

According to one embodiment, the plate is a plate, preferably metal, having a curvilinear transverse profile. The choice of metal allows the realization of a plate with a reduced thickness, and the curvilinear profile allows the plate to better fit the profile of the bony parts. The subject of the invention is also an assembly comprising an implantable medical device for the joining of bone parts separated from one another by a fracture, osteotomy or arthrodesis line, with a view to a fusion of said parts. bones and a piercing template for assisting implantation of said medical device. The invention also relates to a method for implanting a medical device in the human or animal body, for the joining of bone parts separated from each other by a fracture line osteotomy or arthrodesis , with a view to melting said bone parts, characterized in that the device comprising a staple and a plate respectively positionable astride the fracture, osteotomy or arthrodesis line, presenting on its so-called internal support surface on the bony portions to fuse at least one anchor stud projecting from the inner face, and adapted to be inserted into one of the bone parts, said method comprises a step of drilling the bone parts at the locations of receiving the anchor pad and the legs of the staple, a step of laying the plate by at least partial insertion of the stud in said corresponding bore, a staple laying step and a step of placing organs, such as screws. anchoring the plate to bone parts.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will be better understood on reading the following description of exemplary embodiments, with reference to the appended drawings in which: FIG. 1 represents a sectional view of a medical device according to the invention in the installed state of the device. - Figure 2 shows a perspective view of the medical device alone. - Figures 3 and 4 show a sectional view of the medical device alone, in the open position of the legs of the clip (Figure 3) and in the closed position of the legs of the clip (Figure 4). - Figure 5 shows a sectional view of a variant of Figure 3, a sleeve having been introduced into the anchor pad of the plate to a bone portion. - Figures 6 and 7 show, in the form of views at least partially in perspective, a plate and a staple in the open position of the legs of the clip (Figure 6) and closed branches of the clip (Figure 7). - Figures 8 to 12 show, in the form of views at least partially in perspective, the various steps of a method for the implantation of a medical device according to the invention.

DETAILED DESCRIPTION

As mentioned above, the medical device 1, object of the invention, implantable in the human or animal body, is more particularly intended to allow a three-dimensional stability of two bone parts during the time required for bone fusion between the two. bone parts, that is to say generally from several weeks to several months.

The medical device 1 is here represented for performing a metatarsophalangeal arthrodesis, that is to say the blocking of the joint between metatarsal and phalanx, but could have applied in a similar manner to an interphalangeal arthrodesis or blocking bone parts separated at least partially from one another by osteotomy or fracture.

The bone portions to be fused using the medical device 1 are thus at least partially separated from each other by a line 21 or a focus called fracture line 21, or osteotomy or arthrodesis as a function of the cause of the separation.

The medical device 1 capable of allowing a fusion of the bone parts thus separated comprises a plate 2 and at least one staple 3, respectively positionable astride the line 21 of fracture, osteotomy or arthrodesis.

In the example shown, only one staple 3 is provided. This U-shaped clip 3 comprises two anchoring branches 4 capable of being inserted on either side of the fracture, osteotomy or arthrodesis line 21 and a connecting bridge 5 for said anchoring branches 4, this bridge 5 connecting the soul of the U.

This clip is a deformable clip between a closed position in which the anchoring legs 4 of the clip 3 converge towards the free end 41 of the anchoring legs 4 and an open position in which the branches 4 anchoring of the staple 3 extend substantially parallel to each other, that is to say parallel to each other within plus or minus 4 °.

In the closed position, the free ends of the clip are therefore close to one another at a distance less than that which separates them in the open position.

In the case of an elastically deformable staple 3 as shown, the anchoring legs 4 of the staple are resiliently biased into the so-called closed rest position. The closed position of the branches of the clip is therefore the rest position of the clip, that is to say the position in which the branches of the clip are not stressed.

In the case of a shape memory staple, the anchoring legs of the staple are returned to the closed position under the effect of heat. Thus, for example, the sole implantation of the staple in the human or animal body can allow, under the effect of the temperature of the human or animal body, a deformation of the staple and the passage of the branches of the staple of the staple. the open position to the closed position.

This clip 3 is preferably metal, in particular titanium. This clip 3 will not be described in more detail because it is well known to those skilled in the art.

The separable plate 2 of the staple 3, but used in combination with the latter, is itself a plate made here of titanium. This plate has a so-called internal face 9, concave, bearing on the bony portions to be fused, and a so-called outer face 10, convex, opposite to the inner face 9. This plate thus has a curvilinear transverse profile.

For attachment to the bone parts, the plate 2 is provided with orifices 13 therethrough, each defining a passage for receiving a member 14, such as a screw anchoring the plate 2 to said bone portions.

In the example shown, the anchoring members 14 are poly-axial screws. Mono axial screws could also have been used in an equivalent way.

In the example shown, the plate is provided with a plurality, in this case four through-holes 13, each serving to delimit a passage for receiving a screw.

The through orifices 13 are arranged in pairs at each end of the plate, which is in the form of an elongated rectangular plate. The longitudinal axes of the passages delimited by said through orifices 13 of a pair of through orifices 13 are non-parallel to one another and intersect on the inner face of support of the plate 2 on the bony portions 20 to be fused. This results in better resistance to tearing the plate.

The plate 2 further comprises, on its internal bearing surface 10 on the bone portions to be fused, an anchor pad 7 projecting from the inner face 10, this anchor pad 7 being adapted to insert into one of the bone parts.

This anchor pad 7 is hollowed out centrally to form a recess 8 inside which a branch 4 anchoring a clip is able to be inserted. This recess 8 thus forms a guide orifice 6 passing through a branch of the staple formed in the plate 2. Thanks to the presence of this anchoring stud 7, the staple takes, at the level of one of its branches, support no longer on the bone, but on the plate, to achieve the compression. This makes it possible to increase the efficiency of the compression, in particular in the case of an osteoporotic bone, compared with a static compression screw. In addition, the presence of this stud simplifies and shortens the operative technique, since the plate can self-position without risk of slipping, before the staple is applied.

If it is desired to avoid direct contact between the pad and the staple, the anchor pad 7 is pre-equipped with a socket 12. This socket 12 is generally made of a polymeric material. This sleeve 12 is here in the form of a cylindrical body, open at each of its ends.

To perfect the device, the anchor pad 7 opens into a slot 11 formed in the plate 2. The slot 11 serves for the insertion of the connecting bridge 5 of the staple 3 in the thickness of the plate 2. This slot is formed along a longitudinal axis of the plate. The thickness of the medical device 1 is thus reduced.

To facilitate the installation of such a medical device 1, this medical device is delivered with a template 22 for drilling and a template 23 for laying that can be common or separate.

To allow the implantation of such a medical device, the procedure is as follows: it is assumed that the bone parts to be fused are in the position of consolidation corresponding to that desired by the surgeon, and that the surgeon has already proceeded to the treatment, for example by milling or sawing, surfaces facing the bony parts to be fused, to allow perfect complementarity of said surfaces. The surgeon proceeds, at first, to the drilling of the bony parts, at least at the locations of the bone parts intended to receive the anchor pad 7 of the plate 2 and the branch of the clip other than that passing through the stud these holes being arranged on either side of the line 21 of fracture osteotomy or arthrodesis, as shown in Figure 9.

In the case of a metatarsophalangeal arthrodesis, as shown, the piercing used to receive the stud takes place in the metatarsal metaphysis and the piercing serving to receive the branch of the staple other than that passing through the stud. , in the subchondral bone of the phalanx.

Drilling the stud is a stepped bore to accommodate the stud and the branch of the clip through said stud. Once these holes have been made, the plate 2 is positioned on the bone parts, by interlocking its anchor stud 7 in the corresponding bore. It is then possible to proceed with the installation of the staple 3 with the aid of a traditional staple-laying pliers 24, as illustrated in FIG.

The branches of the clip are held in the open position by the branches of the clamp, to be inserted into said open position, in the bone parts, via the two holes previously made. During this implementation, one of the branches of the clip through the pad of the plate.

The installation of the clip ensures a compression of the bony parts which tend to approach one another, under the effect of the passage of the branches of the clip from the open position to the closed position, this passage s' operating when the branches of the clip are no longer solicited by the clip of the clip when the staple is an elastically deformable clip.

The fixing of the plate can then be completed. To do this, a template 23 for laying and drilling can be used, to finalize the holes, in particular the bores remaining to be made in the bone parts, in order to receive the anchoring members 14 of the plate 2 to the parts bone. This step is illustrated in Figure 12.

Once the anchoring members 14 are screwed into the bone parts, the assembly is completed, and the fusion of the bone parts by osteosynthesis can begin. It should be noted that it is then possible, at any time, to remove the clip. The advantage of this method is that the surgeon fixes the plate free hands, that is to say without having to deal with the approximation of the bony parts, which are held compressed against each other by the clip.

Claims (10)

  1. Implantable medical device (1) for securing bone parts (20) separated from each other by a line (21) of fracture, osteotomy or arthrodesis, for fusion of said parts (20) bone, characterized in that said device (1) comprises a plate (2) and at least one staple (3) respectively positionable straddling the line (21) of fracture, osteotomy or arthrodesis, the or at least one of the generally U-shaped clips comprising two anchoring legs (4) which can be inserted on either side of the fracture, osteotomy or arthrodesis line (21) and a bridge (5) connecting said anchoring legs (4) forming the core of the U, said staple (3) being a deformable clip between a closed position, in which the legs (4) anchoring the clip (3) converge towards the free end (41) of the anchoring legs (4), and an open position, in which the branches anchoring means (4) extend substantially parallel to each other, the anchoring legs (4) of the resiliently deformable and / or shape memory clip (3) being configured to move from the open position to the closed position by elastic return and / or under the effect of a rise in temperature.
  2. 2. Device (1) medical implantable according to claim 1, characterized in that the plate (2) comprises at least one orifice (6), said guide, through which inside a branch (4) anchoring of the or a staple (3) is adapted to be inserted.
  3. 3. Device (1) implantable medical device according to one of the preceding claims, characterized in that the plate (2) comprises, on its face (10) said internal support on the parts (20) bone to be fused, at least an anchoring stud (7) projecting from the internal face (10) and capable of being inserted into one of the bone parts (20).
  4. 4. Device (1) medical implantable according to claim 3 taken in combination with claim 2, characterized in that the orifice (6) or at least one of the through-guiding orifices, inside which a branch ( 4) anchoring of the or staple (3) is adapted to be inserted, is formed by a recess (8) of the stud (7) anchoring.
  5. 5. Device (1) medical implantable according to one of claims 3 or 4, characterized in that the or at least one of the pads (7) anchor opens into a slot (11) formed in the plate (2). ), said slot (11) for the insertion of the bridge (5) connecting the clip (3) in the thickness of the plate (2).
  6. 6. Device (1) medical implantable according to one of claims 3 to 5, characterized in that the or at least one of the anchor pads (7) is pre-equipped with a sleeve (12).
  7. 7. Device (1) medical implantable according to one of the preceding claims, characterized in that the plate (2) is provided with at least two orifices (13) through, preferably at least four through holes, each defining a passage for receiving a member (14), such as a screw, anchoring the plate (2) to said bone portions (20).
  8. 8. Device (1) medical implantable according to claim 7, characterized in that the longitudinal axes of at least two of the passages defined by the orifices (13) through are non-parallel to each other and cross side face (10) internal d pressing the plate (2) on the bone parts (20) to be fused.
  9. 9. Device (1) medical implantable according to one of the preceding claims, characterized in that the plate (2) is a plate, preferably metal. having a curvilinear transverse profile.
  10. 10. An assembly comprising an implantable medical device (1) for the joining of bone parts (20) separated from each other by a line (21) of fracture, osteotomy or arthrodesis, with a view to a fusion of said bone portions (20) and a piercing template (22) for assisting implantation of said medical device (1), characterized in that the implantable medical device (1) is according to one of claims 1 to 9.
FR1655023A 2016-06-02 2016-06-02 Implantable medical device for solidarizing bone parts separated for fusion Pending FR3052047A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
FR1655023A FR3052047A1 (en) 2016-06-02 2016-06-02 Implantable medical device for solidarizing bone parts separated for fusion

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1655023A FR3052047A1 (en) 2016-06-02 2016-06-02 Implantable medical device for solidarizing bone parts separated for fusion
PCT/FR2017/051356 WO2017207922A1 (en) 2016-06-02 2017-05-31 Implantable medical device for attaching separated bone parts with a view to the fusion of same

Publications (1)

Publication Number Publication Date
FR3052047A1 true FR3052047A1 (en) 2017-12-08

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Application Number Title Priority Date Filing Date
FR1655023A Pending FR3052047A1 (en) 2016-06-02 2016-06-02 Implantable medical device for solidarizing bone parts separated for fusion

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FR (1) FR3052047A1 (en)
WO (1) WO2017207922A1 (en)

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2693899B1 (en) 1992-07-24 1994-09-23 Laboureau Jacques Clip-plate osteosynthesis.
US20040019353A1 (en) 2002-02-01 2004-01-29 Freid James M. Spinal plate system for stabilizing a portion of a spine
FR2905590B1 (en) 2006-09-11 2008-12-05 Surge Foot Arthrodesis plate of a metatarso-phalangeal articulation.
FR2916954B1 (en) 2007-06-05 2011-11-25 Small Bone Innovations Internat Osteosynthesis clip
US8808294B2 (en) * 2008-09-09 2014-08-19 William Casey Fox Method and apparatus for a multiple transition temperature implant
FR2936700B1 (en) 2008-10-02 2012-04-13 Memometal Technologies Orthopedic implant in the form of a plate to be fixed between two bone parts
US9060822B2 (en) 2011-12-28 2015-06-23 Orthohelix Surgical Designs, Inc. Orthopedic compression plate and method of surgery
ES2633746T3 (en) 2011-07-18 2017-09-25 Woodwelding Ag Implant to stabilize each other separate bone portions
US8632574B2 (en) 2011-12-07 2014-01-21 Biomet C.V. Reduced component bone plating system
US20140148859A1 (en) 2012-11-27 2014-05-29 Solana Surgical, Llc Orthopedic fusion plate and compression screw

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Publication number Publication date
WO2017207922A1 (en) 2017-12-07

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