Altivate Reverse Shoulder Primary Humeral Stem - Reverse shoulder prosthesis
Access comprehensive regulatory information for Altivate Reverse Shoulder Primary Humeral Stem - Reverse shoulder prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by DJO Global Pty Ltd, manufactured by Encore Medical LP in United States of America. The device registration started on December 20, 2017.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The AltiVate™ Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: • Noninflammatory degenerative joint disease including osteoarthritis; • Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis; • Post-traumatic arthritis of the glenohumeral joint; • Avascular necrosis of the humeral head with and without involvement of the glenoid; • Correction of functional deformity The AltiVate™ Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to: • Noninflammatory degenerative joint disease including osteoarthritis; • Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis; • Post-traumatic arthritis of the glenohumeral joint; • Avascular necrosis of the humeral head with and without involvement of the glenoid; • Correction of functional deformity; • Rotator cuff tear arthropathy; • Humeral fracture. • Failed previous shoulder surgery The AltiVate™ Shoulder Prosthesis Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: • Severe arthropathy with a grossly deficient rotator cuff; • Previously failed joint replacement with a grossly deficient rotator cuff; • Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; • Bone defect in proximal humerus; • Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; • Inflammatory arthritis including rheumatoid arthritis; • Correction of functional deformity. All humeral stems are intended for cemented or cementless use.