Device Dossier

Affinis Inverse Glenosphere vitamys with Fixation Screw - Reverse shoulder prosthesis head

Device Dossier for Affinis Inverse Glenosphere vitamys with Fixation Screw - Reverse shoulder prosthesis head (Reverse shoulder prosthesis head, Class…

Intended purpose

The Affinis Inverse Glenosphere vitamys forms part of the Affinis Inverse Shoulder System that is designed for treating rotator defect arthropathy, revision of a failed hemiprosthesis or total prosthesis in patients with rotator cuff defect and certain tumour-related modifications of the proximal humerus.

Functional description

The Affinis Inverse Glenosphere vitamys with fixation screw reduces mechanical and biological notching which reduces polyethylene debris, and has limiting empty spaces to reduce the danger of dead tissue accumulation. The glenosphere is more durable due to the oxidation resistant highly cross linked polyethylene vitamys.

TGA Public Summary