Device Dossier

ACS Femoral Component cemented - Uncoated knee femur prosthesis

Device Dossier for ACS Femoral Component cemented - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor Life Healthcare).…

Intended purpose

A cemented femoral component of the ACS knee system for use in knee arthroplasty. Knee arthroplasty with 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 coating. Asymmetric anatomically formed design. The lateral femoral flange is more prominent than the medial one with anteriorly smooth tapered flange. The deep 5° inclined patella groove supports patella alignment and physiological patella tracking. The distal resection plane is inclined by 15° which contributes to maximum preservation of bone stock. The articulating surfaces feature a multi-radius design (J-curve profile). Two femoral pegs for improved bone fixation.

TGA Public Summary