Device Dossier

APEX Tibial Baseplate - Porous Coated - Coated knee tibia prosthesis

Device Dossier for APEX Tibial Baseplate - Porous Coated - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Corin). ARTG…

Intended purpose

The APEX Knee System is intended for use as a primary or revision total knee replacement. 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 Revisions procedures where other treatments or devices have failed;

Functional description

The APEX Modular Tibial Baseplate-Porous Coated component is designed for use in the APEX Primary Knee System only to replace the tibial condyles of the patient and attaches to the tibial insert. Dual Dovetail locking rails on the tibial baseplate mate with any size tibial insert. The porous coated tibial baseplate component may be used uncemented (biological fixation) and is made of Co-Cr with a CPTi and HA coating.

TGA Public Summary