Device Dossier

SMR CTA Humeral Head CoCrMo - Humeral head prosthesis

Device Dossier for SMR CTA Humeral Head CoCrMo - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Enovis Surgical). ARTG record,…

Intended purpose

The CTA Humeral Head is part of the SMR Anatomic and Reverse Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability. In cases with a deficient and unreconstructable rotator cuff, a hemiprosthesis with a CTA head or a Reverse Total Shoulder Arthroplasty is indicated. In cases with significant bone loss and in which adequate fixation on the glenoid side cannot be obtained, a hemiarthroplasty with a CTA-head should be performed.

Functional description

The CTA Humeral Head is made of CoCrMo and is attached to the humeral body via a humeral head adaptor and combined they provide articualtion in the shoulder joint with the natural glenoid fossa or a replacement glenoid fossa prosthesis to provide movement.

TGA Public Summary