Device Dossier

RSP Glenoid Head w/ Retaining Screw - Reverse shoulder prosthesis head

Device Dossier for RSP Glenoid Head w/ Retaining Screw - Reverse shoulder prosthesis head (Reverse shoulder prosthesis head, Class III, sponsor Enovis…

Intended purpose

A component of a reverse shoulder prosthesis system indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

Functional description

A sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal piece (glenosphere) that attaches to the reverse shoulder baseplate with screws (screws included). It articulates with the reverse shoulder cup. It is intended for use without cement.

TGA Public Summary