Device Dossier
Patella trial prosthesis
Device Dossier for Patella trial prosthesis (Patella trial prosthesis, Class IIa, sponsor Amplitude). ARTG record, intended purpose, GMDN category —…
- GMDN category: Patella trial prosthesis
Intended purpose
A copy of a final patella prosthesis designed to be used during knee arthroplasty to determine the correct alignment, size, and fit of the final prosthesis, and to check that patellar tendon tension 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 typically made of metal or polymer material. This is a reusable device that must be sterilized prior to use.