Device Dossier

SCORPIO CRUCIATE RETAINING (CR) FEMORAL COMPONENT - Uncoated knee femur prosthesis

Device Dossier for SCORPIO CRUCIATE RETAINING (CR) FEMORAL COMPONENT - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor…

Intended purpose

A device used to repair or replace the femoral joint of the knee. Indications: Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. Post-traumatic loss of knee joint configuration and function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Revision of previous unsuccessful knee replacement or other procedure.

Functional description

A sterile implantable device designed to replace the femoral articulating surface, intended for use with cement. Designed to be implanted with retention of the posterior cruciate ligament. It is a component of the Scorpio Total Knee System which typically includes femoral, tibial, and patellar components that articulate. Made of Cobalt Chrome.

TGA Public Summary