Device Dossier

Journey II CR CoCr Femoral - Uncoated knee femur prosthesis

Device Dossier for Journey II CR CoCr Femoral - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor Smith & Nephew). ARTG…

Intended purpose

Indications for Total Knee Replacement • Rheumatoid arthritis. • Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. • Failed osteotomies, unicompartmental replacement, or total knee replacement. • Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. • Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent. • Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

Functional description

Journey II CR femoral is a sterile implantable device designed to replace the femoral condyles of the knee joint. The device articulates with tibial inserts and if required, patellar prosthetic components of the knee joint.

TGA Public Summary