Device Dossier

Legion PS XLPE High Flexion Articular Inserts - Prosthesis, knee, internal, insert component

Device Dossier for Legion PS XLPE High Flexion Articular Inserts - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…

Intended purpose

Indications for Total Knee Replacement Include- 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. 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. 4. 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.

Functional description

An implantable device designed to articulate with the femoral component of a knee joint prosthesis during primary knee joint replacement. It is a one-piece contoured crosslinked polyethylene (XLPE)insert which locks into a tibial tray.

TGA Public Summary