Device Dossier

GENUS UNI cemented femoral component - Uncoated unicondylar knee femur prosthesis

Device Dossier for GENUS UNI cemented femoral component - Uncoated unicondylar knee femur prosthesis (Uncoated unicondylar knee femur prosthesis, Class…

Intended purpose

A cemented femoral component of a Medial unicompartmental knee replacement prosthesis. Indicated when; • Medial compartment osteoarthritis or avascular necrosis with a well-preserved lateral compartment presenting an intact meniscus and full thickness cartilage. • Normally functioning Anterior and Posterior cruciate ligaments. • Varus deformity able to be passively corrected and in any case lower than 15°. • Flexion contracture less than 15°. • Patello-femoral arthritis is not considered a contraindication. • Age, weight and patient activity level are not considered a contraindication for Unicompartmental knee replacement.

Functional description

A cemented femoral component of a unicompartmental knee replacement prosthesis composed of CoCrMo alloy. 6mm constant thickness of the implant. Rotation center at constant radius of flexion from 0 to 90 degrees. The 3-degree closure of the posterior condyle increases the range of motion and the stability of the system. External distal apex blunted. Optimizes M/L positioning without risk of protrusion. Outer edge with softened radius.

TGA Public Summary