Device Dossier

Comprehensive Total Shoulder Versa-Dial Humeral Head - Humeral head prosthesis

Device Dossier for Comprehensive Total Shoulder Versa-Dial Humeral Head - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Zimmer…

Intended purpose

Humeral head component of a total shoulder system intended for use in total, reverse or partial shoulder replacement. 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 may not be suitable or may be inadequate.

Functional description

Humeral Head component of a shoulder joint replacement prosthesis made from cast cobalt chrome and provides the articulating surface. Variable offset humeral head allows for proper natural anatomic reconstruction. It is designed to be used with the Comprehensive Standard Taper Adaptor.

TGA Public Summary