Device Dossier

Pty Ltd - Knee tibia trial prosthesis

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

Intended purpose

The tibia trial is a copy of a final tibia 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 femur trial prosthesis and a patella trial prosthesis. It is made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary