Device Dossier

Pty Ltd - Humeral stem trial prosthesis

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

Intended purpose

The humeral stem trial is a copy of a final humeral stem 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 is made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary