Device Dossier

Identity Shoulder System Humeral Vivacit-E Bearings - Reverse shoulder prosthesis cup

Device Dossier for Identity Shoulder System Humeral Vivacit-E Bearings - Reverse shoulder prosthesis cup (Reverse shoulder prosthesis cup, Class III,…

Intended purpose

The Identity Shoulder System Humeral Vivacit-E Bearings are 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

The Identity shoulder System Humeral Vivacit-E Bearings latch into the Humeral Tray, which in turn attaches to an Identity Shoulder System Stem. These components together forn one side of the articulating surface in a replacement shoulder joint in reverse configuration.

TGA Public Summary