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The indications for the Osteonics Solar™ Shoulder Bipolar System are: - Aseptic necrosis of the humeral head . - Painful, disabling joint disease of the shoulder resulting from: degenerative ● arthritis, rheumatoid arthritis or post-traumatic arthritis. - . Proximal humeral fracture and/or dislocation - Clinical management problems where arthrodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results. - Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.

The Osteonics" Solar™ Shoulder Bipolar System consists of an Osteonics Solar™ Shoulder Bipolar Humeral Head Component, an Osteonics 22 mm Solar™ Shoulder Bipolar Modular Head and an Osteonics Solar™ Shoulder Humeral Stem. The humeral stem was determined substantially equivalent via 510(k) K955731. There have been no modifications made to the humeral stem. The bipolar head component consists of three preassembled pieces: a metal shell, UHMWPE insert and locking ring. The component will be sold preassembled. The metallic shell is manufactured from ASTM F75 cobalt chromium alloy. The 22 mm bipolar modular head is manufactured from ASTM 1537 cobalt chromium alloy. The Osteonics Solar™ cobalt chromium Shoulder Bipolar Components (Bipolar Head Component and 22 mm Bipolar Modular Head) are intended to be used in cementless applications and as a hemi-shoulder system. Used as a hemi-shoulder replacement device, the Osteonics Solar™ Shoulder, Bipolar Humeral Head Components are intended to articulate directly with the anatomic glenoid.

The BUECHEL-PAPPAS™ Modular Salvage Shoulder Replacement System is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis, rheumatiod arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis; for use in the absence of a functionally sufficient rotator cuff as well as where the proximal humerus is insufficient to support a standard angled humeral prosthesis. Biocoat® porous coated components are intended for cemented use.

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