Device Dossier

ACS MB SC Tibial Component cementless pc - Coated knee tibia prosthesis

Device Dossier for ACS MB SC 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, TiN & porous coating. The ACS MB SC system (SC-semi-constrained) offers the possibility to connect stem extensions with the femoral and tibial component via offset adapters. The PE-peg is guided in the femoral box and stabilized by the femoral spindle during articulation between femoral and tibial component. Fins provide for the rotational stability of the component. The MB SC tibial component is 2,5mm thicker than the primary MB tibial components.

TGA Public Summary