Device Dossier

APEX Primary Knee System CR Femoral Porous Coated - Coated knee femur prosthesis

Device Dossier for APEX Primary Knee System CR Femoral Porous Coated - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor…

Intended purpose

The APEX Primary Knee System CR Femoral Porous Coated is a component of The APEX Primary Knee System intended to repair or replace the patient’s femoral knee joint in a primary or revision total knee replacement. This prosthesis is intended for non‐cemented 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 Primary Knee System CR Femoral Porous Coated component is designed for use in the APEX Primary Knee System only. The device is made from CoCr and is used without cement. It retains a deep wide patella groove, has been designed with high flex geometry, and has a generously curved sagittal geometry that eliminates edge loading during varus/valgus lift off.

TGA Public Summary