Device Dossier

LEGION HK Guided-Motion Articular Insert - Prosthesis, knee, internal, insert component

Device Dossier for LEGION HK Guided-Motion Articular Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component,…

Intended purpose

The LEGION HK Hinge Knee System is intended to be used with bone cement. Indications for Total Knee Replacement are: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies or total knee replacement. 4. 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

A sterile polyethylene (UHMWPE) asymmetrical insert having a fixed bearing design, with a titanium alloy (Ti-6Al-4V) locking screw. The insert is locked to the cemented tibial tray through a redundant locking configuration to help minimize motion between the tibial tray and distal insert surfaces. The guided-rotation/'screw-home'kinematics of the insert's design was to potentially reduce the complication rates of patellar dislocation/subluxation.

TGA Public Summary