Device Dossier
Affinis Short Stem - Prosthesis, internal, joint, shoulder, total
Device Dossier for Affinis Short Stem - Prosthesis, internal, joint, shoulder, total (Prosthesis, internal, joint, shoulder, total, Class III, sponsor…
- GMDN category: Prosthesis, internal, joint, shoulder, total
Intended purpose
The Affinis Short Stem forms part of the Affinis Short Shoulder System that is designed to treat 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 (if sufficient bone stock).
Functional description
The Affinis Short Stem is coated with titanium and calcium phosphate for uncemented fixation. The stem is bone sparing and has 4 wings for secure metaphysial anchorage.