Device Dossier

Knee femur trial prosthesis

Device Dossier for Knee femur trial prosthesis (Knee femur trial prosthesis, Class IIa, sponsor Zimmer Biomet). ARTG record, intended purpose, GMDN…

Intended purpose

A copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty 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 typically 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 that must be sterilized prior to use.

TGA Public Summary