Device Dossier

GENUS cementless femoral component beads+HA coated - Coated knee femur prosthesis

Device Dossier for GENUS cementless femoral component beads+HA coated - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor…

Intended purpose

A femoral component of a tricompartmental rotating platform prosthesis to be used in PCL (posterior cruciate ligament)retaining/sacrificing TKR (Total Knee Replacement) for primary and revision surgery. Main indications; - Primary and secondary arthrosis - Rheumatoid arthritis - Bone necrosis - Revisions, where other devices or treatments have failed

Functional description

Constructed from CoCrMo-casting alloy with beads + HA (hydroxyapatite) coating. The GENUS femoral component features an anatomical shape and a constant condyle radius in the range from -70 to +90 degrees. In the last portion, the radius of the condyles reduces to increase the range of flexion. Posterior condyles have a posterior inclination of 3 degrees.

TGA Public Summary