Device Dossier

SMR Adaptor 36mm for Reverse Humeral Body Ti6AI4V - Humeral head prosthesis

Device Dossier for SMR Adaptor 36mm for Reverse Humeral Body Ti6AI4V - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Enovis…

Intended purpose

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disable shoulder). The SMR Adaptor 36mm for Reverse Humeral Body is inserted into the SMR Reverse Humeral Body which is attached to the humeral Stem. The intended purpose of the SMR Adaptor 36mm for Reverse Humeral Body is to hold either the SMR Reverse Humeral Head or SMR Reverse CTA Humeral Head in place.

Functional description

The SMR Adapter is inserted into the Reverse Humeral Body to accommodate the fitting of the Reverse CTA Humeral Head. The CTA Humeral head articulates with the Reverse Glenosphere or replacement Glenoid fossa prosthesis to provide movement within the shoulder joint.

TGA Public Summary