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The Acculoc Total Knee System is indicated in knee arthroplasty for relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The Acculoc Total Knee System is designed for cemented use only.

The Acculoc Tibial tray is a component of "Acculoc Total Knee System" cleared under K170753 which consist of Femoral component, Tibial tray, Tibial Insert, Patella components and Instrumentation- Acculoc Total Knee Instrumentation System for use with the implants components. The current premarket notification is related to the addition of the Acculoc Tibial tray manufactured from CoCrMo alloy (Cobalt-chromium-molybdenum alloy), this is same size and same design with the predicate device tibial tray (K170753) and only the material is different. The Tibial tray AP and ML size ranges are exact same as the predicate device Tibial tray (K170753).

The Acculoc Total Knee System 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, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The Acculoc Total Knee System is designed for cemented use only.

The Acculoc Total Knee System is of the fixed bearing type with a posterior stabilized design and cruciate retained design. It is a Patellofemorotibia, polymer.metal/polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.