Device Dossier

GMK Hinge Tibial Insert Fixed - Bicompartmental knee prosthesis

Device Dossier for GMK Hinge Tibial Insert Fixed - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor Medacta). ARTG…

Intended purpose

The GMK Hinge fixed tibial inserts forms part of the GMK HINGE Knee System that is indicated for cases of revision of a primary total knee replacement or for primary total knee replacement when there is evidence of a serious collateral ligaments deficiency and/or bone augmentation is required.

Functional description

The GMK Hinge fixed tibial insert is manufactured from UHMWPE and has an anterior flare. The insert is designed to be used with the GMK Hinge Knee in order to address cases of severe ligamenteous instability and bone defects. The GMK Hinge is an anatomic, soft-tissue friendly and bone preserving knee system that is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

TGA Public Summary