Device Dossier
LEGION HK Femoral Assembly - Rotating hinged total knee prosthesis
Device Dossier for LEGION HK Femoral Assembly - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor Smith &…
- GMDN category: Rotating hinged total knee prosthesis
- Sponsor: Smith & Nephew
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 pre-assembled CoCr and UHMWPE femoral component of a hinge knee. The femoral assembly consists of a non-porous femoral component with an anatomic femoral trochlear groove, assembled with a femoral axle, axle plugs and a link assembly comprised of a hyperextension stop, a post bushing and an axle bushing. It is intended to be cemented.