Device Dossier

Affinis Stem Cemented - Uncoated shoulder humeral stem prosthesis

Device Dossier for Affinis Stem Cemented - Uncoated shoulder humeral stem prosthesis (Uncoated shoulder humeral stem prosthesis, Class III, sponsor…

Intended purpose

The Affinis cemented stem 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 cemented stem has grooves to ensure safe anchoring in the cement coating, and 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