Device Dossier

GMK UNI Full-PE Tibial Component Cemented - Uncoated unicondylar knee tibia prosthesis, polyethylene

Device Dossier for GMK UNI Full-PE Tibial Component Cemented - Uncoated unicondylar knee tibia prosthesis, polyethylene (Uncoated unicondylar knee tibia…

Intended purpose

The GMK UNI Full-PE Tibia forms part of the GMK UNI Knee System that is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components. In unicompartmental knee arthroplasty, only one compartment of the joint is affected (the medial or lateral compartment).

Functional description

The GMK UNI Full-PE tibia allows simple, accurate and time-effective implantation and forms part of the GMK UNI Knee System. The tibia is designed to be used with bone cement and articulate with the GMK UNI femoral component.

TGA Public Summary