Device Dossier
Identity Shoulder System Humeral Head (Ti) - Humeral head prosthesis
Device Dossier for Identity Shoulder System Humeral Head (Ti) - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Zimmer Biomet). ARTG…
- GMDN category: Humeral head prosthesis
Intended purpose
The Identity Shoulder System Humeral Head (Ti) is intended for use as a component of Identity Shoulder System. Indications of the Identity Shoulder System include: Hemiarthroplasty/Conventional Total Application: • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. • Rheumatoid arthritis. • 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. Optional use in revision Reverse Application: The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Functional description
Identity Shoulder System Humeral Head (Ti) are manufactured from Titanium Alloy (Ti6AL4V, ASTMF136). It consists of a series of various sized modular humeral heads with variable offset between 0.5MM and 4.5 mm.They are assembled to a humeral head adaptor via a locking taper for use with Humeral Stem Adapters . They are indicated for patients with suspected cobalt alloy sensitivity.