Device Dossier

Apex Knee System ECiMa PS-C Tibial Insert - Prosthesis, knee, internal, insert component

Device Dossier for Apex Knee System ECiMa PS-C Tibial Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…

Intended purpose

The APEX Knee System ECiMa PS-C Tibial Insert is a component of The APEX Primary Knee System intended to replace the tibial articular surfaces of the knee joint in a primary or revision total knee replacement. The indications for use include the following: o Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; o Rheumatoid arthritis; o Correction of functional deformity; o Revision procedures where other treatments or devices have failed; o Cases that need additional varus/valgus support, limiting varus/valgus liftoff

Functional description

The APEX Knee System ECiMa PS-C Tibial Insert component is designed to replace the tibial articular surfaces of patients who need additional varus/valgus support. The device is made from ECiMa polyethylene and each size is available in various thicknesses to aid in obtaining appropriate soft tissue balance and joint line height. It attaches to the tibial baseplate and is intended to be used with the APEX PS Femur of the same size.

TGA Public Summary