Device Dossier
Scorpio NRG HA CR Femoral Components - Coated knee femur prosthesis
Device Dossier for Scorpio NRG HA CR Femoral Components - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor Stryker). ARTG…
- GMDN category: Coated knee femur prosthesis
- Sponsor: Stryker
Intended purpose
A total knee implant intended to be used in primary or revision joint arthroplasty of the knee. Indications for use of total knee replacement include: Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid 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. Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques.
Functional description
This Total Knee System includes femoral, patella, tibial tray, tibal bearing and bone augmentation components which are designed to be used together to achieve total reconstructive replacement of the knee joint. These femoral components are permanently implantable and are available in various sizes to address varying patient and surgeon requirements for primary and revision applications. All devices feature a coating of HA on their external surface to encourage bone in growth.