Device Dossier

Pty Ltd - Patella trial prosthesis

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

Intended purpose

The patella trial is a copy of a final patella 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, and to check that patellar ligament balancing is correct. 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. It is made of metal or polymer material. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary