Device Dossier

GMK UNI Tibial Tray Fixed Cemented - Uncoated unicondylar knee tibia prosthesis, metallic

Device Dossier for GMK UNI Tibial Tray Fixed Cemented - Uncoated unicondylar knee tibia prosthesis, metallic (Uncoated unicondylar knee tibia prosthesis,…

Intended purpose

The GMK UNI fixed cemented tibial trays 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 cemented tibia forms part of the GMK UNI Knee System. The tibia has a stabilisation fin and an oblique fixation peg to ensure optimal primary fixation and ease implant positioning.

TGA Public Summary