Device Dossier

Medacta Shoulder System Glenoid Polyaxial Screw - Shoulder prosthesis screw

Device Dossier for Medacta Shoulder System Glenoid Polyaxial Screw - Shoulder prosthesis screw (Shoulder prosthesis screw, Class III, sponsor Medacta).…

Intended purpose

Device intended for use as a hemi or total shoulder replacement. It is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. The humeral components are for cemented and cementless use.

Functional description

Device manufactured from titanium alloy and enhanced with Type-II anodization. They are designed to aid fixation of the Glenoid Baseplate to bone.

TGA Public Summary