Device Dossier

Apex Knee Revision Tibial Baseplate - Uncoated knee tibia prosthesis, metallic

Device Dossier for Apex Knee Revision Tibial Baseplate - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class III,…

Intended purpose

The APEX Revision Tibial Baseplate is a sterile component of 'The APEX Knee System', which is intended for use as a complex primary or revision total knee replacement. The indications for use include: · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; · Rheumatoid arthritis; · Correction of functional deformity; and · Revision procedures where other treatments or devices have failed

Functional description

The APEX Revision Tibial Baseplate component is designed for use in the APEX 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 component may also mate with tibial stem, augment and/or peg components. The underside of the component has a system of channels that facilitate both cement fixation, and is made of Co-Cr.

TGA Public Summary