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).…

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.

TGA Public Summary