Device Dossier

Arthrex® Univers Revers™ SutureCup CaP-Coated - Metallic reverse shoulder prosthesis cup

Device Dossier for Arthrex® Univers Revers™ SutureCup CaP-Coated - Metallic reverse shoulder prosthesis cup (Metallic reverse shoulder prosthesis cup,…

Intended purpose

Arthrex® Univers Revers™ SutureCup CaP-coated is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Functional description

Arthrex® Univers Revers™ SutureCup CaP-Coated sits in the humeral stem and articulates with the glenosphere.

TGA Public Summary