Device Dossier

APEX PS Tibial Insert - Prosthesis, knee, internal, insert component

Device Dossier for APEX PS Tibial Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III, sponsor…

Intended purpose

The APEX Knee System PS 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. This prosthesis is intended for use only in the Apex Primary Knee System and may be used for the following conditions, as appropriate: · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; · Rheumatoid arthritis; · Correction of functional deformity; · Revision procedures where other treatments or devices have failed;

Functional description

The APEX Knee System PS Tibial Insert component is designed to replace the tibial articular surfaces of the patient. The device is made from UHMWPE 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