Device Dossier

GMK Sphere Primary Tibial Insert Fixed - Bicompartmental knee prosthesis

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

Intended purpose

The GMK Sphere fixed tibial insert 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 tibial insert is deigned to maximise contact area for lower contact stresses and reduced poly delamination. The GMK Sphere Knee System is designed to provide stability throughout the range of motion, high flexion and natural kinematics.

TGA Public Summary