Device Dossier

Columbus AS CR PS Tibial Plateau Cemented - Uncoated knee tibia prosthesis, metallic

Device Dossier for Columbus AS CR PS Tibial Plateau Cemented - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class…

Intended purpose

Used for replacing the proximal tibial bone surface (tibia 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 fixed bearing, CR/PS design tibial component made from CoCrMo with AS coating used for replacing the proximal tibial bone surface (tibia component) during bicondylar replacement of the knee joint. The device corresponds to the selected gliding surface size. Cement pockets with a depth of 1mm are provided on the cementing surface. The AS coating consisting of CrN-CrCN-ZrN is designed to prevent the release of metal ions from the implant and to avoid metal allergies in patients.

TGA Public Summary