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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).

The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff. Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by: - Rheumatoid arthritis . - Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) . - Correction of functional deformity . - Humeral head fractures . ● - Traumatic arthritis . The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.

The SEVIIN Surface Replacement Shoulder is a hemi or total shoulder prosthesis designed for use in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed. Additionally, the SEVIIN Surface Replacement Shoulder can be revised to a longer stemmed total shoulder if necessary. The Resurfacing Humeral Heads are manufactured from Co-Cr-Mo alloy conforming to ASTM F799 and have a polished spherical surface for atticulation. The inner surface of the humeral heads is coated with titanium plasma spray. Three sizes of humeral heads are available: 42mm, 48mm and 52mm diameter with a stem that is tapered and fluted to provide stability in the humerus. The Surface Replacement humeral heads are compatible with the previously cleared SEVIIN Total Shoulder Glenoids (K043346) for total shoulder replacement.

The SEVIN Reverse Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty 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 humeral component is intended for cemented use and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation.

The SEVIIN Reverse Shoulder is a total shoulder prosthesis designed for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prostheses. The reverse shoulder is designed so that the "ball" of the articulation is on the glenoid side and the mating "cup" fits into the humeral stem. The components of the system include a Ti-6A1-4V alloy metaglene plate with titanium plasma spray coating, Ti-6Al-4V alloy bone screws, a Co-Cr-Mo alloy glenosphere, a Co-Cr-Mo alloy humeral cup and an ultra high molecular weight polyethylene (UHMWPE) inlay. These components are intended for use with the previously cleared SEVIIN humeral stems (cleared as the Genesis humeral stems). The metaglene plate incorporates a cannulated cancellous central screw with cross holes and 4 peripheral screws for added stability. The screws have a 4.5mm diameter and are available in lengths of 24mm, 33mm and 42mm. The glenosphere mates with the metaglene plate via a taper lock and a glenosphere screw. The glenosphere is available in 36 and 40 mm diameter sizes with standard and +4 mm offsets. The humeral cup mates with the humeral stem via a taper lock. The humeral cup is available in standard and +9 mm offsets. The proximal side of the humeral cup incorporates a snapfit mechanism and anti-rotation tabs that mate with the poly inlay. The poly inlay is a concave liner that is intended to articulate with the glenosphere proximally and attach to the humeral cup distally. The poly inlay is available in 36 mm diameters, centered and retentive, with 0, +3, and 6 mm offsets.