Device Dossier

ACS FB SC PE Insert - Prosthesis, knee, internal, insert component

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

Intended purpose

A PE insert component of the ACS SC knee system (SC-semi-constrained). Indicated in revision of primary knee joint replacement with concurrent loss/damage of both cruciate ligaments and instability of the collateral ligaments with the presence of femoral and/or tibial bone defects. 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 SC PE-insert is very similar in design to the FB PS PE-insert. The central peg of the SC PE-insert is somewhat wider to ensure an increased guidance in the box of the SC femoral component. Peg width 16.6mm.

TGA Public Summary