Arthrex? UNIVERS? Fracture Stem - Uncoated shoulder humeral stem prosthesis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Arthrex Australia Pty Ltd

Class:

Class III

Manufactured by:

Arthrex Inc 1370 Creekside Boulevard, Naples, Florida, 34108-1945 United States Of America

Therapeutic area:

34197 - Uncoated shoulder humeral stem prosthesis

Therapeutic indications:

A sterile base stem of the Univers II shoulder prosthesis placed in the proximal humerus having adjustable humeral head height for the management of fracture jigs and lateral fin positions with suture eyelets for anatomic reconstruction of the tuberosities. The Arthrex Univers? Fracture Stem Shoulder Humeral Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures, comminuted fracture, humeral head fracture, displaced 3- or 4- fragment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck. The Arthrex Univers? Shoulder Humeral Fracture Prosthesis is intended for cemented or non-cemented use. This device may be used for hemi or total shoulder repair.

Authorization status:

A

Authorization date:

2018-08-30