Device Dossier
LEGION HK Tibial Baseplate - Uncoated knee tibia prosthesis, metallic
Device Dossier for LEGION HK Tibial Baseplate - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class III, sponsor…
- GMDN category: Uncoated knee tibia prosthesis, metallic
- 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 nonporous CoCr tibial baseplate component of a hinge knee. The baseplate features an anatomic asymmetric design for patient anatomic requirements. It is intended to be cemented.