Device Dossier

Pty Ltd - Knee stem

Device Dossier for Pty Ltd - Knee stem (Knee stem, Class IIb, sponsor Advita Ortho AUS). ARTG record, intended purpose, GMDN category — compiled by…

Intended purpose

The Stem Extension & Screw, Femoral and Tibial, Cemented is a sterile device designed to provide additional stability for an implanted knee femur or tibial prosthesis by extending the attachment of the prosthesis from the distal femur or tibia prosthesis into the midshaft of the bone. It includes screws for fixation to the femur or tibia prosthesis.

TGA Public Summary