Device Dossier

Humeral body trial prosthesis

Device Dossier for Humeral body trial prosthesis (Humeral body trial prosthesis, Class IIa, sponsor Enovis Surgical). ARTG record, intended purpose, GMDN…

Intended purpose

A copy of the final humeral body prosthesis designed to be used during primary or revision surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It connects to a humeral stem prosthesis and articulates with a standard humeral head prosthesis, or connects to a reverse shoulder prosthesis cup.

TGA Public Summary