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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 Skeletal Dynamics Total Wrist Arthroplasty System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.

The subject Total Wrist Arthroplasty System is a total joint replacement of the wrist. The system has four major components: a radial component, a carpal component, a poly "lunate" component, and screws which fix the carpal component to the carpus.

The Skeletal Dynamics Protean Fragment Plating System is intended for stabilization and fixation in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, clavicle, scapula, finger, toe, and pelvis, particularly in osteopenic bone with the appropriate configuration of the device. The system is intended for use in adult and pediatric populations (children and adolescents).

The Skeletal Dynamics Protean Fragment Plating 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 small bone fragments 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 FreeFix Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.

The FreeFix Forearm Plating System is comprised of plates, screws and specific instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

The Suture Button Repair System is intended for fixation of bone and soft tissue in upper extremity orthopedic procedures requiring ligament or tendon reconstruction in the hand, wrist, forearm, elbow and shoulder.

The Suture Button Repair System is comprised of the following Suture Button configurations in conjunction with accessories: (1) Distal Bicep Suture Button Repair configuration, (2) IOL Suture Button-Repair configuration and (3) CMC Suture Button Repair configuration. The implants are provided sterile for single use. The instruments are provided non-sterile and shall be sterilized by the end user.

The Skeletal Dynamics Total Wrist Arthroplasty System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.

The subject Total Wrist Arthroplasty System is a total joint replacement of the wrist. The system has four major components: a radial component, a carpal component, a poly "lunate" component, and screws which fix the carpal component to the carpus.

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

The Predicate Internal Joint Stabilizer - Elbow (IJS-E) System consists of a titanium base plate, with the following components: 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 Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using a cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments. The subject Double Internal Joint Stabilizer - Elbow (IJS-E) System is modifying the predicate IJS-E Base Plate to add an additional set of components to the other side of the IJS-E Base plate. The Proximal Connecting Rods from each side of the Double IJS-E base plate are secured to the distal humerus at the axis of rotation using the predicate male axis pin from one side and the new female axis pin from the other side. The male axis pin telescopes within the female axis pin within the distal humerus. The subject Double Internal Joint Stabilizer - Elbow Base Plate is attached to the Ulna by the same 3.5mm compression screws as the predicate IJS-E system (K153208). 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. The system is provided non-sterile and is sterilized in the user facility.

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 subject Align Radial Head System and the predicate Align Radial Head System (K172688) are a radial head prosthesis and instrumentation platform that is designed to orient the radial head perpendicular to the axis of forearm rotation. It consists of cobalt chrome modular heads in different sizes with cobalt chrome locking screws, titanium alloy stems, necks, and specialized instrumentation.

The Skeletal Dynamics Distal Elbow Plating System is indicated for fixation of fractures, osteotomies and nonunions of the radius and ulna, particularly in osteopenic bone.

The predicate Skeletal Dynamics Distal Elbow Plating System (K171590) consists of medical grade titanium alloy radial head plates, proximal ulna plates, double hockey stick, Y and coronoid plates designed for fracture fixation, fusions, osteotomies and non-unions of the proximal radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation. The system is provided non-sterile and is sterilized in the user facility. The modifications to the currently marketed Distal Elbow Plating System include the following. - . Two new Proximal Ulna Plate extension options - New 3.5mm FreeFix™ screw options . - Addition of Protean Radial Head Plate configurations. . - Addition of Modified Proximal Ulna Plate configurations. .

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.