Device Dossier

Identity Shoulder System Humeral Trays - Reverse shoulder prosthesis body

Device Dossier for Identity Shoulder System Humeral Trays - Reverse shoulder prosthesis body (Reverse shoulder prosthesis body, Class III, sponsor Zimmer…

Intended purpose

The Identity Shoulder System Humeral Trays 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 Trays are 40mm in diameter manufactured from titanium alloy (Ti-6Al-4V). Trays are offered in 4 heights, -6, 0, +6 and +12, which vary the distance between the tray and the center of rotation of the head. Extended and Standard options allow the surgeon to vary the perpendicular distance between the axis of the humerus and the center of rotation of the head.

TGA Public Summary