Device Dossier

Arthrex® Univers Revers™ CaP Coated Stem - Coated shoulder humeral stem prosthesis

Device Dossier for Arthrex® Univers Revers™ CaP Coated Stem - Coated shoulder humeral stem prosthesis (Coated shoulder humeral stem prosthesis, Class…

Intended purpose

Arthrex® Univers Revers™ CaP Coated Stem 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™ CaP Coated Stem is designed for cementless procedures, though cement may be used as indicated. The box‐shape geometry and incremental stem sizes provide metaphyseal rotational stability.

TGA Public Summary