Device Dossier
RESTORIS MCK Onlay Tibial Insert - Uncoated unicondylar knee tibia prosthesis, polyethylene
Device Dossier for RESTORIS MCK Onlay Tibial Insert - Uncoated unicondylar knee tibia prosthesis, polyethylene (Uncoated unicondylar knee tibia…
- GMDN category: Uncoated unicondylar knee tibia prosthesis, polyethylene
- Sponsor: Stryker
Intended purpose
A tibial implant used in unicompartmental knee arthroplasty as a result of; Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis; Revision of previous unsuccessful unicompartmental knee replacement; As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. Or intended for single or multi-compartmental knee replacement when used in conjunction with RIO - the Mako Robotic Arm Interactic Orthopaedic System.
Functional description
A sterile implantable Tibial Insert, designed to articulate with an artificial Femoral Component on the corresponding condyle and connected with a Tibial Baseplate for fixation. A component of the RESTORIS® MCK (MultiCompartmental Knee). Made from polyethylene (UHMWPE). For cemented use only.