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This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis,collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device system is designed for cement use only.

The Prolixus™ Cruciate Retaining (CR) Total Knee System consists of three primary components: Cruciate Retaining (CR) Femoral Component, Cruciate Retaining (CR) Tibial Insert, Patellar component and Tibial base plate. The Prolixus™ CR components are described below: PROLIXUSTMTotal Knee Cruciate Retaining (CR) Femoral Component Prolixus™ Total Knee Cruciate Retaining (CR) Femoral Component is fabricated from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to replace the articulating surface of the distal femur. This cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present. The Cruciate Retaining (CR) Femoral Component is available in right and left configurations, and six proportional sizes (sizes A to F) to accommodate differences in patient anatomy. The interior surface of the component is grit-blasted to increase surface roughness - this is intended to promote interdigitation of the polymethylmethacrylate (PMMA) bone cement with the surface texture and the apposing bone. This femoral component features cast-in pegs to help in femoral component placement, and to provide rotational stability. PROLIXUS™ Cruciate Retaining (CR) Tibial Insert The Cruciate Retaining (CR) Tibial Insert is neutral in configuration, and is available in six proportional sizes (sizes 1 to 6) and varying thicknesses (10mm, 12mm,14mm, 16mm, 18mm and 20 mm). The insert is fabricated from ultra high molecular weight polyethylene(medical grade PUR 1020 UHMPE) .The tibial insert is designed to accommodate the posterior cruciate ligament if it is present. There is a relief on the anterior aspect of the tibial insert to accommodate the patellar tendon and patellar fat pad. PROLIXUS™ Tibial base plate Stem tibial baseplate components (tibial baseplate) are made from Ti-The angled 6Al-4V titanium alloy. Tibial baseplates are available in 6 sizes (1 to 6). PROLIXUS™ | Patellar components patellar component is made from ultra high molecular weight The polyethylene(medical grade PUR 1020 UHMPE). The patella is available in five diameters, 26mm, 29mm, 32mm, 35mm and 38mm, which permit optimal bone coverage and surgical options.