Device Dossier
Aequalis Reversed Fracture Humeral Insert - Reverse shoulder prosthesis
Device Dossier for Aequalis Reversed Fracture Humeral Insert - Reverse shoulder prosthesis (Reverse shoulder prosthesis, Class III, sponsor Stryker).…
- GMDN category: Reverse shoulder 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 polyethylene humeral insert allows for optimal deltoid tension and implant stability while avoiding risk of acromial impingement. Both centered (standard) and constrained insert options are available.