Device Dossier

Pty Ltd - Reverse shoulder head trial prosthesis

Device Dossier for Pty Ltd - Reverse shoulder head trial prosthesis (Reverse shoulder head trial prosthesis, Class IIa, sponsor Advita Ortho AUS). ARTG…

Intended purpose

The reverse shoulder head trial is a copy of a final reverse shoulder prosthesis head 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 hemisphere-shaped (glenosphere) and made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary