Device Dossier

Identity Shoulder System Humeral Stem - Coated shoulder humeral stem prosthesis

Device Dossier for Identity Shoulder System Humeral Stem - Coated shoulder humeral stem prosthesis (Coated shoulder humeral stem prosthesis, Class III,…

Intended purpose

The Identity Shoulder System Humeral Stem 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

The Identity Shoulder System Humeral Stem Components are manufactured from Tivanium® Ti-6Al-4V alloy with a titanium porous plasma spray (PPS) coating. They are available in 17 diameters 4 mm to 20 mm in 1 mm increments and lengths of 75 and 95 mm. The humeral stems employ an oval reverse taper which allows the attachment of either an Identity Humeral Stem Adapter for hemi and anatomic total shoulder applications or an Identity Humeral Tray for reverse shoulder applications.

TGA Public Summary