Device Dossier
Identity Shoulder System Humeral Head Adaptor - Humeral head prosthesis
Device Dossier for Identity Shoulder System Humeral Head Adaptor - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Zimmer Biomet).…
- GMDN category: Humeral head prosthesis
Intended purpose
The Identity Shoulder System Humeral Head Adaptor is intended for use as a component of Identity Shoulder System. Indications of the Identity Shoulder System include: Hemiarthoplasty/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
The Identity Humeral Heads are assembled to a Humeral Head Adaptor via a locking taper for use with the Humeral Stem Adaptors. The Humeral Head Adaptor is impacted into the head in a certain position to achieve the desired amount of offset. There is one size of Humeral Head Adaptor, manufactured from Ti-6Al-4V.