Device Dossier

Aequalis Reversed Fracture Humeral Stem - Coated shoulder humeral stem prosthesis

Device Dossier for Aequalis Reversed Fracture Humeral Stem - Coated shoulder humeral stem prosthesis (Coated shoulder humeral stem prosthesis, Class III,…

Intended purpose

A component of the Aequalis Reversed Fracture Shoulder Prosthesis indicated for patients with functional deltoid muscle as a total shoulder replacement for the relief of pain/significant disability following arthropathy associated to a grossly deficient rotator cuff joint: in case of traumatic/pathologic conditions of shoulder resulting in fracture of the glenohumeral joint, including head fracture and displaced 3 or 4 part proximal fractures; or in case of bone defect in the proximal humerus.

Functional description

The device forms the humeral stem component of a semi-constrained reversed shoulder prosthesis. It is a monobloc stem that is intended for use with a specific articular insert that is congruent with the glenoid sphere. The stem is made of titanium alloy and coated with hydroxyapatite. It is intended for cemented use only.

TGA Public Summary