Device Dossier

Pty Ltd - Reverse shoulder cup trial prosthesis

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

Intended purpose

The reverse shoulder cup trial is a copy of a final reverse shoulder prosthesis cup 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 reverse shoulder prosthesis body and articulates with a reverse shoulder prosthesis head and is made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary