Device Dossier

Comprehensive Reverse Shoulder Glenosphere - Reverse shoulder prosthesis head

Device Dossier for Comprehensive Reverse Shoulder Glenosphere - Reverse shoulder prosthesis head (Reverse shoulder prosthesis head, Class III, sponsor…

Intended purpose

A component of a reverse shoulder prosthesis system indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

Functional description

Glenosphere component of reverse shoulder joint replacement prosthesis made from cobalt chrome alloy with medialized or lateralized center of rotation. Contains infinite offset options that can be positioned in any direction and is designed to be used with a taper adaptor.

TGA Public Summary