Device Dossier

APEX Primary Knee System Congruent Tibial Insert Cruciate Retaining - Prosthesis, knee, internal, insert component

Device Dossier for APEX Primary Knee System Congruent Tibial Insert Cruciate Retaining - Prosthesis, knee, internal, insert component (Prosthesis, knee,…

Intended purpose

The APEX Primary Knee System Congruent Tibial Insert Cruciate Retaining is a component of The Apex Knee System intended to replace the tibial articular surface in a primary or revision total knee replacement. The Congruent Tibial Insert is used in knee joint replacement surgery where the cruciate ligament is intact. This prosthesis may be used for the following conditions, as appropriate: o Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; o Rheumatoid arthritis; o Correction of functional deformity and o Revision procedures where other treatments or devices have failed.

Functional description

The APEX Primary Knee System Congruent Tibial Insert Cruciate Retaining component is designed to attach to the tibial baseplate of the APEX Primary Knee System and replace the tibial articular surface of the patient. The device is made from UHMWPE and is intended for use only in the Apex Primary Knee System and where the cruciate ligament is intact.

TGA Public Summary