Device Dossier
UNIX UNICONDYLAR KNEE TIBIAL INSERTS - Uncoated unicondylar knee tibia prosthesis, polyethylene
Device Dossier for UNIX UNICONDYLAR KNEE TIBIAL INSERTS - Uncoated unicondylar knee tibia prosthesis, polyethylene (Uncoated unicondylar knee tibia…
- GMDN category: Uncoated unicondylar knee tibia prosthesis, polyethylene
- Sponsor: Stryker
Intended purpose
A modular unicondylar knee that replaces the bearing surfaces of one femoral condyle and the corresponding tibial condyle, to achieve reconstruction replacement of the deficient knee component. Indication: Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis. Revision of previous unsuccessful unicompartmental knee replacement or other procedure. As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
Functional description
A sterile implantable Tibial Insert, designed to be connected with a Tibial Tray/ Baseplate for fixation and articulates with an artificial Femoral Component on the corresponding condyle. A component of the Unix unicompartmental Knee System intended to replace the bearing surface of one tibial condyle (medial or lateral condyle) of the knee joint. made of polyethylene (UHWMPE).