Device Dossier

RESTORIS MCK Femoral Component - Uncoated unicondylar knee femur prosthesis

Device Dossier for RESTORIS MCK Femoral Component - Uncoated unicondylar knee femur prosthesis (Uncoated unicondylar knee femur prosthesis, Class III,…

Intended purpose

A femoral 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 used in conjunction with RIO - the Mako Robotic Arm Interactic Orthopaedic System.

Functional description

A sterile implantable device designed to replace the bearing surface of one femoral condyle of the knee joint. This device is a component of the RESTORIS® MCK (MultiCompartmental Knee which articulates with a tibial insert that is connected to a tibial baseplate. Made of Cobalt Chrome. For cemented use only.

TGA Public Summary