Device Dossier

ACS FB Tibial Component cementless pc - Coated knee tibia prosthesis

Device Dossier for ACS FB Tibial Component cementless pc - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Life…

Intended purpose

A cementless tibial component of the ACS knee system for use in knee arthroplasty. The ACS Knee System is indicated, if - severe joint destruction with significant impairment where other therapeutic measures are not more promising. - severe joint pain due to degenerative or rheumatoid arthritis, joint fractures or bone necrosis. - post-operative conditions after previous surgery with or without the use of implants.

Functional description

CoCrMo alloy with TiN & Porous Coating. Asymmetric design. Pronounced fins provide rotational stability of the component. 5 degree inclination of the plateau compared to the axis of the stem. The cementless tibial component features 4 holes filled with titanium plugs. If required the plugs can be removed to fix the component with additional anchorage screws in the proximal tibia. For additional primary stability an extension stem (25mm) is pre-assembled to the cementless tibial component.

TGA Public Summary