Device Dossier

SMR Stemless Adaptor Screw - Shoulder prosthesis screw

Device Dossier for SMR Stemless Adaptor Screw - Shoulder prosthesis screw (Shoulder prosthesis screw, Class III, sponsor Enovis Surgical). ARTG record,…

Intended purpose

The SMR Stemless System is intended for partial or total, primary or revision shoulder joint replacement. Revision surgery is intended only where the Stemless Core is stable, well positioned and osseointegrated and it is intended only as revision of a failed SMR Stemless primary implant with an anatomic implant or a conversion from anatomic to reverse or CTA or from reverse to CTA or in case of a failed SMR Resurfacing implant. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses. The SMR Stemless Anatomic System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: • non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; • inflammatory degenerative joint disease such as rheumatoid arthritis; • revision of a failed SMR Stemless primary implant with conversion from anatomic to reverse; • revision of a failed SMR Resurfacing implant; • cuff tear arthropathy (CTA Heads only). The SMR Stemless Reverse System is indicated for primary or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

Functional description

The Adaptor Screw is made of Ti6Al4V and is used as a safety screw in an uncemented setting to secure the coupling between the adaptor Taper and the Stemless Core. The screw should be tightened using the Counter Torque attached to the Multipurpose Handle in order to prevent load transmission.

TGA Public Summary