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The Howmedica® Total Stabilizer Knee Components (Stabilizer femoral component, stabilizer tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges) are intended to be used along with previously released Duracon® tibial and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis.

The Howmedica® Total Stabilizer femoral component and tibial insert components are specifically intended to be used when the cruciate ligaments are absent, inadequate, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to the absence of the posterior cruciate ligament and/or patella. The collateral ligaments may or may not be intact. In addition, these components may be used in revision of a failed previous prosthesis where the cruciate ligaments are absent.

The Howmedica® tibial wedges are intended to be used with the Howmedica® Universal tibial baseplate to augment bone loss on the surface of the tibia. Tibial bone loss may be observed in primary or revision total knee arthroplasty.

The Howmedica® Modular Offset Adaptor is intended to be used in situations where a stem extender is being used, and the tibial baseplate or femoral component requires offsetting with respect to the intramedullary canal to allow optimal coverage of the prepared bone surfaces.

The Howmedica® Stem Extenders are intended to be used with Duracon®/ Kinemax® femoral/tibial components in primary/revision total knee arthroplasty where additional stability is required.

The Howmedica® Total Stabilizer Knee Components are intended to be implanted using bone cement.

The Howmedica® Total Stabilizer Knee Components (Stabilizer femoral component, stabilizer tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges) are intended to be used along with previously released Duracon® tibial and patellar components as a total knee system in primary or revision cemented total knee arthroplasty.

This document is a 510(k) summary for the Howmedica Total Stabilizer Knee Components, submitted in 1997. It describes the intended use and substantial equivalence of the device but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically found in contemporary regulatory submissions for AI/ML-based devices.

The content focuses on stating the intended use of the knee components and asserting their substantial equivalence to other legally marketed devices, along with referencing the FDA Total Knee Guidance Document. The FDA's letter of clearance also highlights specific limitations and conditions for marketing the device, primarily related to cemented use.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, etc.) because it is not present in the provided text. This 510(k) predates the detailed rigor expected for AI/ML device submissions regarding performance evaluation.

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