Device Dossier

EVOLUTION® Revision Tibial Base Non-Porous - Uncoated knee tibia prosthesis, metallic

Device Dossier for EVOLUTION® Revision Tibial Base Non-Porous - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class…

Intended purpose

A total knee system component used to replace the proximal tibia. Indicated for use in knee arthroplasty in skeletally mature patients with the following condition: 1) revision procedures where other treatments or devices have failed.

Functional description

A nonporous titanium alloy (Ti6Al4V) tibial base device used to replace the proximal tibia of a knee joint in skeletally mature patients. It is designed to mate with EVOLUTION® tibial inserts and articulate with EVOLUTION® femur components. Tibial bases are offered in anatomic sizes 1-8 in either “standard” or “plus” sizes.

TGA Public Summary