Arthrex? UNIVERS? Fracture Humeral Head - Humeral head 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:

48088 - Humeral head prosthesis

Therapeutic indications:

An uncoated artificial humeral head designed to be attached to the Univers Fracture humeral stem prosthesis and to articulate against an artificial or natural glenoid fossa. The Arthrex Univers? Fracture Humeral Head Shoulder 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