Device Dossier
APEX Primary Knee System ECiMa Congruent Tibial Insert Cruciate Retaining - Prosthesis, knee, internal, insert component
Device Dossier for APEX Primary Knee System ECiMa Congruent Tibial Insert Cruciate Retaining - Prosthesis, knee, internal, insert component (Prosthesis,…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The APEX Primary Knee System ECiMa 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 ECiMa 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 ECiMa 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 ECiMa polyethylene and is intended for use only in the Apex Primary Knee System and where the cruciate ligament is intact.