Device Dossier
Aequalis Reversed Fracture Humeral Stem - Coated shoulder humeral stem prosthesis
Device Dossier for Aequalis Reversed Fracture Humeral Stem - Coated shoulder humeral stem prosthesis (Coated shoulder humeral stem prosthesis, Class III,…
- GMDN category: Coated shoulder humeral stem prosthesis
- Sponsor: Stryker
Intended purpose
A component of the Aequalis Reversed Fracture Shoulder Prosthesis indicated for patients with functional deltoid muscle as a total shoulder replacement for the relief of pain/significant disability following arthropathy associated to a grossly deficient rotator cuff joint: in case of traumatic/pathologic conditions of shoulder resulting in fracture of the glenohumeral joint, including head fracture and displaced 3 or 4 part proximal fractures; or in case of bone defect in the proximal humerus.
Functional description
The device forms the humeral stem component of a semi-constrained reversed shoulder prosthesis. It is a monobloc stem that is intended for use with a specific articular insert that is congruent with the glenoid sphere. The stem is made of titanium alloy and coated with hydroxyapatite. It is intended for cemented use only.