Device Dossier
LEGION Porous HA Tibial Base without Holes - Coated knee tibia prosthesis
Device Dossier for LEGION Porous HA Tibial Base without Holes - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Smith &…
- GMDN category: Coated knee tibia prosthesis
- Sponsor: Smith & Nephew
Intended purpose
Indications for use include rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
Functional description
The device has a porous platform, complete with intraoperative flexibility and fixation option and is made from titanium alloy and has Ti sintered bead coating for in-growth capability and HA coating. The proximal surface of the device has a tibial locking mechanism in order to be used interchangeably with the GENESIS II and LEGION Total Knee Systems. The distal fixation surface has fixation stem and rounded spike design. The device is to be implanted without cement.