Device Dossier
GMK Primary Fixed Tibial Tray TiNbN Coated Cemented - Coated knee tibia prosthesis
Device Dossier for GMK Primary Fixed Tibial Tray TiNbN Coated Cemented - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor…
- GMDN category: Coated knee tibia prosthesis
Intended purpose
The GMK Cemented TiNbN Cemented Fixed 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 Fixed 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, and the inlay clipping mechanism assures time-effective and safe implantation. The TiNbN coated fixed tibial trays must not be coupled with any stem extension.