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The BUECHEL-PAPPAS (B-P) Fixed Bearing New Jersey (NJ) Total Knee Replacement System is intended for the reconstruction of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Additionally, it is intended for Subjects with severe arthritis (e.g. Posttraumatic, rheumatoid or osteoarthritis.). with sufficient bone stock (i.e. cortical bone present to support the platform of the components) and ligamentous support (i.e. intact medial and lateral collateral ligaments) to allow stable, anatomical positioning of components and supporting tissue structures, who are skellatly mature and have not responded to conservative treatment (i.e. injections, therapy, etc.). Porous components and textured components are intended for cemented use.

Buechel-Pappas (B-P) Fixed Bearing New Jersey Total Knee Replacement System

I am sorry. I cannot provide the information you are requesting. The document you provided is a 510(k) clearance letter for a medical device (Buechel-Pappas (B-P) Fixed Bearing New Jersey Total Knee Replacement System). This type of document confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device.

It does not contain details about acceptance criteria, specific performance studies, sample sizes, expert qualifications, or comparative effectiveness studies as described in your request. These details would typically be found in the more comprehensive 510(k) submission itself, which is not publicly available in this format, or in associated scientific literature or clinical trial reports for the device.

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