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The Proximal Humerus Fixtion System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The Skeletal Dynamics Proximal Humerus Fixation System is a set of medical-grade Titanium Alloy (Ti-6Al-4V ELI) bone plates and Titanium and Cobalt Chrome (CoCr) screws and pegs designed for the stabilization and repair of fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus in conjunction with general and specialized instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

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

The Skeletal Dynamic's Internal Joint Stabilizer Elbow System (K153208) consists of a titanium base plate, with a Distal Connecting Rod and Proximal Connecting Rod, held together by adjustable locking joints and locking screws which allow for multiple degrees of freedom. The system is being modified to include an Internal Joint Stabilizer - Elbow titanium base plate applied to the Company's cleared Proximal Ulna Plates of the Distal Elbow Plating System (K171590), instead of directly to the ulna as does the base plate of the cleared Internal Joint Stabilizer Elbow System. The subject Internal Joint Stabilizer- Elbow is attached to the cleared Proximal Ulna Plates by means of two #4-40 cobalt chrome screws of 5.5mm in length and the Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using the cleared cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments. The modified system provides internal stabilization to the elbow joint in the same manner, function, and technology as the Company's cleared Internal Joint Stabilizer Elbow. The system includes specialized instrumentation. When attached to the cleared Skeletal Dynamics proximal ulna plate, the Internal Joint Stabilizer Elbow sits on the same anatomical location over the ulna and under the musculature and soft tissue, as does the cleared Internal Joint Stabilizer - Elbow. The system is provided non-sterile and is sterilized in the user facility.

The Hand Trauma Threaded Nail System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized threaded nail.

The Skeletal Dynamic's Hand Trauma Threaded Nail System consists of cannulated and noncannulated threaded nails, with distal and proximal threads with a pitch differential between the threads which creates compression during threaded nail insertion. The threaded nails are selftapping, available in multiple diameters and various lengths and made of titanium alloy. - 2.0mm non-cannulated Hand Trauma Threaded nail:12mm-28mm in 2mm increments - 2.0mm non-cannulated Hand Trauma Threaded Nails: 28mm 48mm in 4mm increments. - · 3.0mm cannulated Hand Trauma Threaded Nails: 20mm 70mm in 5mm increments. - · 3.5mm cannulated Hand Trauma Threaded Nails: 25mm 70mm in 5mm increments. - · 4.0mm cannulated Hand Trauma Threaded Nails: 25mm 70mm in 5mm increments. The system is provided non-sterile and is sterilized in the user facility.

The Hand Trauma Screw System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw.

The Skeletal Dynamic's Hand Trauma Screw System consists of titanium screws and specialized instrumentation. - 2.0mm non-cannulated Hand Trauma Screws: 24mm 48mm in 4mm increments. ● - 3.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments. - 3.5mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments. - 4.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments. The system is provided non-sterile and is sterilized in the user facility.

The Skeletal Dynamics Inc's Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The Skeletal Dynamics Inc's Distal Humerus Plating System consists of five titanium bone plates in different shapes (medial direct, lateral direct, lateral capitellar, and supracondylar), in multiple lengths, and in left and right configurations to address distal humerus fractures. The plates are made of medical grade titanium allov. The system also includes 2.7mm, 3.5mm and 4.5mm locking and compression titanium alloy screws and 3.0mm polyaxial Cobalt Chrome locking screws which are provided in various lengths. The System is being modified to include additional lengths of existing screw options and new 3.5mm and 4.5mm locking and compression Titanium Alloy Screws. Additionally, minor modifications have been made to the plates to accept the new screws above mentioned. Also included in the system is specialized instrumentation. The System is provided nonsterile for sterilization in the user facility. The Distal Humerus Plating System is comprised of: - · Titanium alloy plates, screws, and fasteners - · CoCr Cannulated Polyaxial Locking Screws (PLS) - · Stainless steel K-wires (for provisional fixation; not for implantation) - · System specific instrumentation

The Skeletal Dynamics Small Bone Nailing System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal phalanges.

The Skeletal Dynamics Small Bone Nailing System consists of intramedullary nails and screws with diameters of 2.1mm, 3.0mm, and 4.0mm, and lengths from 25mm to 70mm to address proximal phalanx and metacarpal fractures. The intramedullary nails and screws are made of medical grade titanium allov. Cobalt Chrome 1.7mm transfixion screws are also provided in various lengths. Included in the system is specialized instrumentation. The System is provided non-sterile for sterilization in the user facility. The Small Bone Nailing System is comprised of: - Titanium alloy intramedullary nails and screws - CoCr locking screws and transfixion screws - Stainless steel K-wires (for provisional fixation: not for implantation) - System specific instrumentation

The Skeletal Dynamics Ulnar Shortening Plating System is indicated for fractures and osteotomies, in particular for the ulna.

The Skeletal Dynamics Ulnar Shortening Plating System consists of Distal Ulnar Shortening Plates with left and right configurations in two lengths and Proximal Ulnar Shortening Plates in two lengths. The Ulnar Shortening Plates are from medical grade Titanium Allov (ASTM F136). Included within the Ulnar Shortening Plating System Set are 3,5mm cortical locking and non-locking bone screws as well as 2.3mm and 2.7mm locking and non-locking pegs from medical grade Titanium Alloy (ASTM F136) for fixation and class 1 surgical instrumentation.

The Skeletal Dynamics REDUCT® Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw.

The REDUCT® Headless Compression Screw (HCS) System consists of the following screws from medical grade Titanium Alloy (ASTM F136). - · 2.5mm cannulated HCS screws: 10mm 30mm - 3.5mm cannulated HCS screws: 10mm 50mm - 4.5mm cannulated HCS screws: 20mm 65mm - · 2.0mm non-cannulated HCS Arthrodesis screws: 20mm 34mm - 2.5mm cannulated HCS Arthrodesis screws: 26mm 40mm - 3.5mm cannulated HCS Arthrodesis screws: 32mm 46mm The REDUCT® Headless Compression Screw includes appropriate instrumentation, as identified in the surgical technique.

The Skeletal Dynamics Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.

The Skeletal Dynamics Forearm Plating System include Midshaft Radius Plates and Midshaft Ulna Plates, manufactured from titanium alloy (ASTM F-136) and available in multiple lengths and hole configurations.

The Skeletal Dynamics Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The Skeletal Dynamics Distal Humerus Plating System consists of five titanium bone plates in different shapes (medial direct, lateral direct, lateral capitellar, and supracondylar), in multiple lengths, and in left and right configurations to address distal humerus fractures. The plates are made of medical grade titanium alloy. Locking and compression screws in 2.7mm, 3.5mm and 4.5mm and 3.0mm polyaxial locking screws are provided in various lengths. Also included in the system is specialized instrumentation. The System is provided non-sterilization in the user facility. The Distal Humerus Plating System is comprised of: - . Titanium alloy plates, screws and fasteners - CoCr Cannulated Polyaxial Locking Screws (PLS) . - Stainless steel K-wires (for provisional fixation: not for implantation) ● - System specific instrumentation ●