Device Dossier

Legion Constrained Articular Inserts - Prosthesis, knee, internal, insert component

Device Dossier for Legion Constrained Articular Inserts - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component,…

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

A sterile implantable device designed to articulate with a posterior stabilised or constrained femoral component during knee joint replacement. It is a one-piece conventional polyethylene(UHMWPE) insert that utilizes the anterior and posterior dovetail locking mechanism of a cemented tibial tray to lock into place.

TGA Public Summary