Device Dossier

Comprehensive Shoulder System Standard Taper Adaptor - Humeral head prosthesis

Device Dossier for Comprehensive Shoulder System Standard Taper Adaptor - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Zimmer…

Intended purpose

Taper adaptor for use as a component of the Comprehensive Shoulder System. Indications include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. Rheumatoid arthritis. Revision where other devices or treatments have failed. Correction of functional deformity. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment are deemed inadequate.

Functional description

Comprehensive Shoulder System Standard Taper Adaptor. Made from titanium alloy. The adaptor has two male tapers (one mates with the head, one mates with the stem), which are offset from each other. This allows the head to have variable offset. Use with Biomet comprehensive shoulder system.

TGA Public Summary