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The Klassic® Knee System is intended for prosthetic replacement of the following:

• Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
• Patients with failed previous surgery where pain, deformity, or dysfunction persists
• Correctable varus-valgus deformity and moderate flexion contracture
• Revision of a previously failed knee arthroplasty
• Patients who require a total knee replacement.

The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

The Klassic® Knee System employs prostheses designed to help surgeons restore knee joint biomechanics intra-operatively. The purpose of this 510(k) is to add the posterior stabilizing Klassic® Knee Femur, PS-Post; Klassic Femoral Pegs; and the Klassic® Tibial Insert, PS-Post with Standard Poly; and the Klassic® Tibial Insert, PS-Post with E-Link® Poly; to the Klassic Knee System. The subject femoral and tibial components are available in various sizes and thicknesses to match patient anatomy.

The document provided is a 510(k) premarket notification letter from the FDA to Total Joint Orthopedics, Inc. regarding their Klassic Knee System. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations. While it mentions that "All results met the predetermined acceptance criteria," it does not provide the specific acceptance criteria or the detailed study results that prove the device meets these criteria.

Therefore, I cannot extract the requested information from this document.

Missing Information:

• Detailed Acceptance Criteria: The document states that "All results met the predetermined acceptance criteria," but it does not list what those criteria are.
• Specific Device Performance Data: While it mentions types of engineering analysis and testing (e.g., Modular Peg Strength Analysis, Knee Simulator Wear, Tibial Insert Post Fatigue), it does not provide the reported performance values that resulted from these tests.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set Information): None of this detailed study information is present in the provided FDA letter. This type of information would typically be found in the 510(k) submission summary or a more detailed technical report, not in the FDA's clearance letter itself.

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