Device Dossier

RSP Humeral Socket Insert - Standard - Reverse shoulder prosthesis cup

Device Dossier for RSP Humeral Socket Insert - Standard - Reverse shoulder prosthesis cup (Reverse shoulder prosthesis cup, 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 component of a reverse shoulder prosthesis. It is a polyethylene insert that is accommodated within the metal cup (shell) that attaches to a humeral stem prosthesis. The insert articulates with the reverse shoulder head. It is used without cement.

TGA Public Summary