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1) When used as a hemi-hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant. 2) When used as a total hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant. 3) In addition, the NexFlex Total Hip System is intended for cases where alternative modes of treatment appear less preferable and the associated risks of a total hip replacement are thought to be acceptable. It is intended for severely disabled joints, which could result from arthritis or late stages of avascular necrosis and revisions of unsuccessful acetabular cup arthroplasty and/or femoral procedure.

The NexFlex™ Total Hip System is a sterile total or hemi-hip replacement system. It consists of a series of femoral and acetabular implants that are used to help restore patient range of motion and aid in the treatment of other deformities as histor in the Indications for Use. The purpose of this 510(k) is to provide for HA coated hip sterns and acetabular cups. This submission also includes additions / modifications to the and accedural under formal change control procedures.

The NexFlex Total Knee System is indicated for: - Painful, disabling joint disease resulting from rheumatoid arthritis, post-traumatic . arthritis, osteoarthritis, or degenerative arthritis - . Failed osteotomies, unicompartmental replacement, or total knee replacement - 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 The NexFlex Total Knee System is intended for cemented use only.

The NexFlex Total Knee System consists of femoral components, tibial base components, tibial inserts, all-polyethylene tibial components, cancellous bone screws, a tibial screw hole cap, tibial stem extensions, and patellar components. The components of this system are designed to be used together and cannot be used as part of another system, nor can components of another system be incorporated into use with the NexFlex Total Knee System. NexFlex femoral components are manufactured from cobalt-chromium alloy and are available in a range of sizes and in left and right orientations. They are available with or without a commercially pure titanium plasma sprayed inner surface. Tibial base components are manufactured from titanium (Ti-6Al-4V) alloy and are available in a range of sizes. They are available with or without a commercially pure titanium plasma sprayed distal surface. Tibial inserts are manufactured from ultra-high molecular weight polyethylene and are available in a range of sizes to match the tibial base components. The distal side of the tibial inserts has geometry to allow a mechanical lock to the tibial base components of corresponding size. The proximal side of the tibial inserts has geometry that allows articulation with the femoral components. Tibial inserts are available with two different proximal geometries, allowing for different amounts of constraint and contact area with the femoral components. A number of thicknesses of inserts are offered. All-polyethylene tibial components are manufactured from ultra-high molecular weight polyethylene and are available in a range of sizes and thicknesses. These components have distal geometry similar to the tibial base components and proximal geometry similar to the tibial inserts. Cancellous bone screws are manufactured from titanium (Ti-6Al-4V) alloy and are available in a range of lengths. The screws are designed to go through the tibial base component to secure it to the proximal tibia. Tibial screw hole caps are manufactured from titanium (Ti-6Al-4V) alloy. They are designed to thread into the tibial base components to cover the screw holes when a cancellous bone screw is not used. Tibial stem extensions are manufactured from titanium (Ti-6A1-4V) alloy and are available in a range of diameters and lengths. The stems are designed to mate with the tibial base components by means of a mechanical engagement. Patellar components are manufactured from either ultra-high molecular weight polyethylene or a combination of ultra-high molecular weight polyethylene and titanium (Ti-6Al-4V) alloy. They are designed with posterior geometry that allows articulation with the femoral components. Patellar components with titanium backing have a commercially pure titanium plasma spraved anterior surface.