Device Dossier

Pty Ltd - Knee femur trial prosthesis

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

Intended purpose

The Femur trial is a copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set of trial knee prostheses that match the different anatomical structures of the knee joint, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary