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The Active Knee Total Knee Replacement System is indicated to be used only with bone cement in patients suffering from the following conditions:

• Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
• Inflammatory degenerative joint disease including rheumatoid arthritis.
• Correction of functional deformity such as varus, valgus, or flexion deformities.
• Revision procedures where other treatments or devices have failed.
• Treatment of fractures that are unmanageable using other techniques.
  The device is intended for single use only.

The Active Knee System is a modular knee system consisting of a femoral component, a meniscal (tibial) insert, a tibial base plate implant and a patella. The tibial base plates and patella components included in this submission have been previously cleared in K021740. The femoral components are a design iteration of the femoral components cleared in K021740. The Ultracongruent Plus tibial inserts included in this submission are similar to the Ultracongruent tibial inserts previously cleared in K021740 but are designed with a higher anterior lip for use in patients with an absent or severely deficient posterior cruciate ligament.
The Active Knee System femoral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F75 and are available in sizes 1 - 5. Sizes 2, 3, 4, and 5 are also available in a narrow version. The femoral components are asymmetric and are available in right and left versions.
The Active Knee System tibial base plates are manufactured from Co-Cr-Mo alloy conforming to ASTM F75 and are available in sizes 1-5. All sizes are available in narrow and wide versions.
The Active Knee System Ultracongruent Plus tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPe) conforming to ASTM F648 and are available in sizes 1 - 5. Sizes 2, 3 4, and 5 are also available in narrow versions. The tibial inserts are available in thicknesses ranging from of 6.0 to 17.5mm.
The Active Knee System patella implants are manufactured from UHMWPe conforming to ASTM F648 and are available in sizes 1 - 5.

I am sorry, but based on the provided document, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) summary for a medical device (Active Knee Total Knee Replacement System) and primarily focuses on device description, intended use, and substantial equivalence to previously cleared devices. It does not contain details about performance studies with acceptance criteria, sample sizes, expert involvement, or ground truth establishment.

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