Device Dossier

AS Columbus REV F Tibia Offset Cemented - Uncoated knee tibia prosthesis, metallic

Device Dossier for AS Columbus REV F Tibia Offset Cemented - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class…

Intended purpose

The implant is used as a component part of a human knee endoprosthesis in combination with Columbus Revision components during revision of primary knee arthroplasty. Both osseous defects and soft tissue dysfunctions can be treated with Columbus Revision. 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 • Used as revision implants in cases where primary implants have failed

Functional description

The AS Columbus REV F Tibia is a fixed bearing tibial component made from CoCrMo with a multi-layer CrN-CrCN-ZrN coating, which prevents the release of metal ions. The device is compatible with all Columbus Revision Gliding Surfaces with the option for stem extensions and spacers to compensate for bone defects. A mechanism is integrated in the REV F tibia plateau to provide +/- 4mm for size 0 and for the other sizes +/- 6mm medial/lateral off-set of the attachable tibia stems.

TGA Public Summary