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Hemi or Total Shoulder:

The SEVIIN Fracture Shoulder is intended for cemented use for a severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. It is also intended for fracture dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. The device can be used in other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of failed primary component). Hemi-shoulder replacement is also indicated for un-united humeral head fractures and avascular necrosis of the humeral head.

Reverse Shoulder:

The SEVIIN Fracture Shoulder is also indicated for fracture total shoulder arthroplasty (due to acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint) for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SEVIIN Fracture Shoulder humeral stems are intended for cemented applications. The glenoid components are intended for cemented use (total shoulder arthroplasty) and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation (reverse arthroplasty).

The SEVIIN Fracture Shoulder is a hemi or total shoulder prosthesis designed for use in patients with acute fracture of the proximal humerus. The modularity of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder. Additionally, the SEVIIN Fracture Shoulder can be used with the SEVIIN Reverse shoulder for relief of pain or significant disability associated with a grossly deficient or non-repairable rotator cuff joint if necessary.

The Fracture Humeral Stems are manufactured from Ti-6Al-4V utanium alloy conforming to ASTM F136 and have a corundum blasted proximal surface to enhance bone cement fixation. Lateral fins with suture holes are designed for soft tissue attachment. The device features an anatomical neck/shaft angle and a 6 degree taper to mate with humeral heads (hemi or total shoulder) or a humeral cup (reverse shoulder).

Five sizes of fracture stems are available: 8, 10, 12mm diameter x 120mm and 8 and 10mm diameter x 200mm with a polished and fluted distal stem.

The Fracture humeral stems can be used with the SEVIIN Total Shoulder Humeral Heads and Glenoids (K043346) in addition to SEVIIN Reverse Shoulder components (K120374).

This 510(k) summary explicitly states that no non-clinical or clinical testing was performed to demonstrate substantial equivalence for the SEVIIN Fracture Shoulder. Therefore, there are no acceptance criteria or study results to report in the format requested.

The device's substantial equivalence determination was based on the comparison of its intended use, indications, materials, sizes, and design to legally marketed predicate devices. The FDA concluded that the noted differences did not raise new types of safety and effectiveness questions or new technological issues.

In summary, none of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) is available because no studies were conducted.

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