Device Dossier

Altivate Reverse Shoulder Primary Humeral Stem - Reverse shoulder prosthesis

Device Dossier for Altivate Reverse Shoulder Primary Humeral Stem - Reverse shoulder prosthesis (Reverse shoulder prosthesis, Class III, sponsor Enovis…

Intended purpose

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.

Functional description

The stem is a single component with a cylindrical distal body with four flutes. The stem’s body flares proximally to a trapezoidal cross-sectional midbody with a hemispherical shell with porous coating on shell. The stem distal surfaces are polished to prevent intramedullary fixation within the humeral diaphysis.

TGA Public Summary