Device Dossier

Pty Ltd - Humeral body trial prosthesis

Device Dossier for Pty Ltd - Humeral body trial prosthesis (Humeral body trial prosthesis, Class IIa, sponsor Advita Ortho AUS). ARTG record, intended…

Intended purpose

The humeral body trial is a copy of a final humeral body prosthesis designed to be used before primary or revision implant 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, and is made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary