Device Dossier

GMK Sphere Primary Cemented Femoral Component - Bicompartmental knee prosthesis

Device Dossier for GMK Sphere Primary Cemented Femoral Component - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor…

Intended purpose

The GMK Sphere cemented femurs 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 femur has a spherical medial condyle which allows stability in flexion and a flat lateral condyle that allows rotation around the medial sphere. The GMK Sphere Knee System provides stability through the entire range of motion.

TGA Public Summary