Device Dossier

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

Device Dossier for ACS FB PE insert Ultra - 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

Composed of UHMW-PE. The symmetric ACS FB PE-inserts are fixed to the tibial component via a snap-fit mechanism. The FB PE-insert ultra features a highly congruent articulation between femoral component and PE-insert. Thereby an increased stability is provided in flexion and extension.

TGA Public Summary