(169 days)
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.
Therefore, I cannot extract the information to fill out the table or answer the subsequent questions.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.