(119 days)
- A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condvie.
- B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy)
- C. Failed osteotomy or unicompartmental replacements.
- D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
- F. Moderate valgus, varus, or flexion deformities
- G. All CONSENSUS® RKS femoral components and tibial baseplates are intended FOR CEMENTED USE ONLY.
- H. All CONSENSUS® RKS stems are intended FOR PRESS-FIT NON-CEMENTED USE.
Not Found
This document is an FDA 510(k) clearance letter for a medical device (Consensus® Revision Knee System), not a study report. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving device performance.
The letter acknowledges the substantial equivalence of the Consensus® Revision Knee System to legally marketed predicate devices, based on the information provided by the manufacturer in their 510(k) submission. However, it does not describe the specific tests or studies performed by the manufacturer to demonstrate substantial equivalence, nor does it detail acceptance criteria or device performance data.
Key reasons why the requested information is absent:
- Type of Document: This is a regulatory clearance letter, not a scientific study publication or a technical report from the manufacturer.
- Focus of 510(k) Program: The 510(k) pathway is primarily about demonstrating substantial equivalence to a predicate device, not necessarily proving de novo safety and effectiveness through extensive clinical trials (unless specifically required). The FDA reviews the manufacturer's provided data, but this letter doesn't present that data.
- Information Scope: The document lists the device's indications for use and regulatory details, but it does not delve into the technical specifications, testing protocols, or performance metrics that would be part of a detailed study.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The requested details would typically be found in the manufacturer's 510(k) submission document itself, which is not provided here.
§ 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.