Altivate Reverse Shoulder Primary Humeral Stem - Reverse shoulder prosthesis

Risk Class

Class III

Product Type

Single Device Product

ARTG Category

General

Start Date

December 20, 2017

Effective Date

January 31, 2024

Name

DJO Global Pty Ltd

Name

Encore Medical LP

Country

United States of America

Address

9800 Metric Boulevard, Austin, TX, 78758-5445

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.