Device Dossier

Journey II CR Insert XLPE - Prosthesis, knee, internal, insert component

Device Dossier for Journey II CR Insert XLPE - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…

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 Inserts are implantable devices designed to articulate with the femoral component of a knee joint prosthesis during primary knee joint replacement. it is manufactured from cross-linked polyethylene (XLPE) insert which locks into a tibial tray.

TGA Public Summary