Device Dossier

GMK Revision Cemented Fixed Tibial Tray - Bicompartmental knee prosthesis

Device Dossier for GMK Revision Cemented Fixed Tibial Tray - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor…

Intended purpose

The GMK Revision cemented tibial tray forms part of the GMK Revision Knee System which is indicated for cases of revision of a primary total knee replacement or for primary total knee replacement when bone augmentation is required and/or there is evidence of a moderate collateral ligaments deficiency.

Functional description

The GMK Revision cemented tibial tray is part of the GMK Revision Knee System that is designed for the restoration of anatomical alignment and functional stability, the accurate reestablishment of the joint line and the fixation and stabilisation of the revision prosthetic implant components. The tibial tray can be used with or without a stem extension and tibial augments.

TGA Public Summary