Device Dossier

ACS FB PE insert hyperflex - Prosthesis, knee, internal, insert component

Device Dossier for ACS FB PE insert hyperflex - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…

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

The symmetric ACS FB PE?inserts are fixed to the tibial component via a snapfit mechanism. An increased AP?radius compared to the femoral component results in increased translational movements between femoral component and PE?insert. Constructed of UHMWPE

TGA Public Summary