Device Dossier

GMK Sphere Primary Cemented Tibial Tray Fixed - Bicompartmental knee prosthesis

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

Intended purpose

The GMK Sphere cemented tibias form part of the GMK Sphere 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 Sphere cemented tibia forms part of the GMK Sphere Knee System that is designed to provide stability throughout the range of motion, high flexion and natural kinematics.

TGA Public Summary