Device Dossier

Affimis CoCr Head - Humeral head prosthesis

Device Dossier for Affimis CoCr Head - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Enovis Surgical). ARTG record, intended…

Intended purpose

The Affinis cobalt chrome head forms part of the Affinis Total Shoulder System that is designed for treating shoulder conditions such as Primary Osteoarthritis, Secondary Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis, Cuff Tear Arthropathy (Hamada grade III or IV) in younger patients, Metabolic joint destruction (e.g. chondrocalcinosis, haemo- siderosis, urate arthropathy)), fracture sequelae (malformation healing of humeral head fractures, non union healing/ pseudarthrosis, head necrosis, locked dislocations) and avascular head necrosis.

Functional description

The Affinis CoCr head provides an adjustable posterior offset with an eccentric head trunnion. The head forms part of the Affinis Total Shoulder Prosthesis which offers precise adjustability to the existing anatomy to restore the center of rotation and exact reconstruction of the proximal humerus.

TGA Public Summary