Device Dossier
Mako X3 Uni Onlay Tibial Insert - Uncoated unicondylar knee tibia prosthesis, polyethylene
Device Dossier for Mako X3 Uni 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
Indicated for use 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 or as an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
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 highly cross linked ultra high molecular weight polyethylene (UHMWPE). For cemented use only.