Device Dossier

Columbus AS CR Femoral Component Cemented - Uncoated knee femur prosthesis

Device Dossier for Columbus AS CR Femoral Component Cemented - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor B…

Intended purpose

Used for replacing the femoral condyles (femoral component) during bicondylar replacement of the knee joint. Indicated for severe knee joint conditions that cannot be treated through other therapies: * Degenerative osteoarthritis * Rheumatoid arthritis * Posttraumatic arthritis * Symptomatic knee instability * Knee stiffness * Deformation of the knee joint

Functional description

A CoCrMo fixed bearing femoral component to replace the femoral condyles during bicondylar knee replacement. The device can be combined with all sizes of CR, UCR, DD, RP and UC gliding surfaces. Cement pockets with a depth of 1mm are provided on the cementing surface and two fixation pegs are provided on the distal base surface of the device for medio-lateral stabilisation of the prosthesis in the bone. The AS coating prevents the release of metal ions from the implant.

TGA Public Summary