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The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius

The Skeletal Dynamics Geminus Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates. The Geminus Volar Distal Radius Plates are available in various sizes and are made of medical grade titanium alloy. Cortical screws affix the plate to the diaphysis and fixed angle pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility. The Geminus Volar Distal Radius Plate System is comprised of: - Titanium alloy plates, washers and screws - CoCr Cannulated Polyaxial Locking Screw (PLS) - Stainless steel K-wires (for provisional fixation; not for implantation) - System specific instrumentation

The Stablyx CMC Arthroplasty Implant System is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis or post fracture deformation or bone loss which present as either painful, unstable thumb or a thumb with limited range of motion. The implant is intended for uncemented, press fit use.

The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) ioint. The single piece prosthesis has a highly polished. saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates aqainst the saddle surface of the trapezium, allowing for flexion-extension, abduction-adduction and opposition motions. The prosthesis is available in fixe sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile. The Stablyx CMC Arthroplasty System is comprised of: Multiple sized hemi joint prosthesis System specific instrumentation

The Align Radial Head System and accessories are designed specifically for · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: - o Joint destruction and/or subluxation, - o Resistance to conservative treatment. - · Primary replacement after fracture of the radial head. - · Symptomatic sequelae after radial head resection. - · Revision following failed radial head arthroplasty. The system is intended for press fit use.

The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit. Combined with its unique instrumentation, the Align Radial Head System offer the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved. The Align Radial Head System is comprised of: - · Multiple sized CoCr Radial Heads with Locking Screw - Multiple sized titanium alloy Stems, titanium plasma spray coated - · System specific instrumentation.

The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.

The Skeletal Dynamics Distal Elbow Plating System is comprised of: - Titanium alloy plates and screws in various configurations - Cobalt chrome polyaxial screws - Stainless steel K-wires (for provisional fixation not for implantation) - System specific instrumentation The current Skeletal Dynamics Distal Elbow Plating System (K140892) includes the radial head and proximal ulna plates. Plates in double hockey stick, Y and coronoid shape configurations with the same node and inter-node features as the radial head plate are being added for use in the proximal radius and ulna in this submission. All plates are made of medical grade titanium alloy. The radial head, proximal ulna and coronoid plates are offered in left and right applications, the proximal ulna plate is provided in various lengths, and the double hockey stick and Y plates are in single size and have bilateral application. Additional screws length as well as new threaded pegs, washers, polyaxial locking screws, and instruments have been added in the subject system in this submission. The system is provided non-sterile and is sterilized in the user facility.

The Internal Joint Stabilizer – Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

The Skeletal Dynamics Internal Joint Stabilizer – Elbow is an internal elbow fixator, with three principal components: - A Base Plate assembly consisting of a low profile Base Plate, contoured to fit within . the flat surface of ulna at the olecranon process; a Connecting Rod, a Boom and two Locking Joints designed to bridge over the anconeous muscle. The Connecting Rod and Boom are adjustable by means of the Locking Joints to accommodate different patient anatomies. The Base Plate assembly is made of titanium alloy and cobalt chrome. - A cobalt chrome Axis Pin threads through the Boom of the Base Plate assembly and ● is inserted in the axis of rotation of the humerus, and - . Titanium compression screws to attach the Base Plate Assembly to the ulna. Specialized instrumentation includes Axis Trajectory Guides (available in 3 sizes), K- Wire Guide, K-Wires, Depth Gauges, Drills, a Counter-torque tool, and a T-10 driver and quick connect handle. The Internal Joint Stabilizer - Elbow is intended to be removed once the elbow ligaments have healed, usually within 6 - 8 weeks after implantation. The system is provided non-sterile and is sterilized in the user facility.

The Skeletal Dynamics Dorsal Spanning Plate is intended for fixation of fractures involving the distal radius and for wrist arthrodesis.

The Skeletal Dynamics Dorsal Spanning Plate consists of a bone plate designed for fracture fixation of the distal radius and wrist arthrodesis. Included in the system are titanium bone screws, k-wires, and specialized instrumentation. The system is provided non-sterile and is sterilized in the user facility. The Skeletal Dynamics Dorsal Spanning Plate is comprised of: Titanium alloy plate and screws; Stainless steel K-wires (for provisional fixation not for implantation); System specific instrumentation.

The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The screws are available in 11 length configurations between 10mm - 30mm, with increments of 2mm. The system is provided non-sterile and is sterilized in the user facility.

The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.

The Skeletal Dynamics Distal Elbow System consists of various bone plates designed for fracture fixation, fusions, osteotomies and non-unions of the radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation. The Radial Head and the Proximal Ulna plates are made of medical grade titanium alloy. They are offered in left and right applications. The Proximal Ulna plate is provided in various lengths. The system is provided non-sterile and is sterilized in the user facility. The Skeletal Dynamics Fragment Plate System is comprised of: - · Titanium alloy plates and screws - Cobalt chrome polyaxial screws - · Stainless steel K-wires (for provisional fixation not for implantation) - · System specific instrumentation.

The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly in osteopenic bone.

The Skeletal Dynamics Protean Fragment Plate System is a set of titanium bone plates designed for stabilization and repair of small bone fragments. Included in the set are titanium bone screws, fixation pegs, cobalt chrome cannulated polyaxial screws, and specialized instrumentation. The Fragment Plates are available in 3 configurations and are made of medical grade titanium alloy. The system is provided non-sterilized in the user facility. The Skeletal Dynamics Protean Fragment Plate System is comprised of: Titanium alloy plates and screws, Cobalt chrome polyaxial screws, Stainless steel K-wires (for provisional fixation not for implantation), System specific instrumentation.

The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.

The Geminus Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates. The Geminus Volar Distal Radius Plate is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis, fixed angle pegs are used for distal bone fragments. The titanium Hook Plate Extension locks to the plate by a means of titanium screw. The system is provided non-sterile and is sterilized in the user facility. The Geminus Volar Distal Radius Plate System is comprised of: - · Titanium alloy plates, washers and screws - · Cannulated cobalt chrome polyaxial locking screws - · Titanium alloy hook plate extension - · Stainless steel k-wires (for provisional fixation not for implantation) - · System specific instrumentation.