Device Dossier

GMK UNI Tibial Insert Fixed - Uncoated unicondylar knee tibia prosthesis, polyethylene

Device Dossier for GMK UNI Tibial Insert Fixed - Uncoated unicondylar knee tibia prosthesis, polyethylene (Uncoated unicondylar knee tibia prosthesis,…

Intended purpose

The GMK UNI fixed tibial inserts form 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 fixed insert is designed to be used as part of the GMK UNI Knee System that provides round-on-flat articulation which avoids unwanted stress on the tibial compartment and the mirror polished fixed tibial baseplate minimises backside wear of the UHMWPE insert component.

TGA Public Summary