Device Dossier

Affinis Uncemented Glenoid vitamys - Prosthesis, internal, joint, shoulder, glenoid component

Device Dossier for Affinis Uncemented Glenoid vitamys - Prosthesis, internal, joint, shoulder, glenoid component (Prosthesis, internal, joint, shoulder,…

Intended purpose

The Affinis Glenoid is a cementless component that is designed to be used in total shoulder replacement for the following indications: Primary osteoarthritis, Secondary osteoarthritis, Rheumatoid arthritis, Posttraumatic osteoarthritis, Cuff tear arthropathy (Hamada grade III or IV) in younger patients, Metabolic joint destruction (e.g. chondrocalcinosis, haemosiderosis, urate arthropathy), Fracture sequelae (malformation healing of humeral head fractures, non-union healing/pseudarthrosis, head necrosis, locked dislocations) and Avascular head necrosis (if sufficient bone stock).

Functional description

The Affinis Uncemented Glenoid vitamys is a one piece construction manufactured from vitamys polyethylene and coated with single pure titanium particles (TiCP). vitamys is designed for durability and longevity and the material has been specially adapted to shoulder loads and force transmission. The glenoid component has flexible pegs for safe and stable anchorage, a sloped rim design to diminish edge loading and TiCP-coating for secondary stability and osseointegration.

TGA Public Summary