Device Dossier

Pty Ltd - Femoral head trial prosthesis

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

Intended purpose

A copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set of hip trial prostheses that match the different anatomical structures of the hip joint, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary