Device Dossier

ACS MB PE insert DD - Prosthesis, knee, internal, insert component

Device Dossier for ACS MB PE insert DD - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III, sponsor…

Intended purpose

A PE insert component of the ACS knee system. 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

Composed of UHMW-PE. The symmetric ACS MB PE-inserts are movable on the tibial component by permitting rotational movements. A deep anterior notch provides space for the patella ligament and surrounding soft tissue, even in deep flexion angles. The posterior notch allows for preservation of the posterior cruciate ligament. The anteriorly raised design leads to an increased congruency between femoral component and PE-insert and thus to increased stability.

TGA Public Summary