Device Dossier

GMK Primary Mobile Tibial Tray TiNbN Coated Cemented - Coated knee tibia prosthesis

Device Dossier for GMK Primary Mobile Tibial Tray TiNbN Coated Cemented - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor…

Intended purpose

The GMK Cemented TiNbN Cemented Mobile Tibial Tray Component forms part of the GMK Primary 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.

Functional description

The GMK Primary Mobile Cemented Tibial Tray is TiNbN Coated and is an asymmetric design which maximises bone coverage, assures optimal load distribution and avoids overhanging risk. The mirror polished surface of the tibial baseplate minimises backside wear. The TiNbN coated mobile tibial trays must not be coupled with any stem extension.

TGA Public Summary