Device Dossier

Humeral stem extension prosthesis

Device Dossier for Humeral stem extension prosthesis (Humeral stem extension prosthesis, Class IIb, sponsor Enovis Surgical). ARTG record, intended…

Intended purpose

A sterile implantable component of a total shoulder prosthesis intended to be fixed to the proximal end of a humeral stem when there has been a large resection of the humerus (e.g., due to trauma or tumour) to achieve the additional length required for connection to a humeral body. It is a modular arrangement of interlocking parts so the length can be configured intraoperatively. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo), or titanium (Ti)] and is used in a modular shoulder replacement system. The modular augment is an optional component.

TGA Public Summary