(90 days)
The Consensus® Knee System and the CoCr/Ti porous or CoCr nonporous tibial baseblate is design for use as a system, and is not intended for substitution with components of other systems. This device is intended for cemented use only. The indications for use are:
- Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis.
- Failed osteotomy or unicompartmental replacements.
- Replacement of unsatisfactory cemented or press fit knee components, if sufficient bone stock exists.
Tibial Baseplate, Cast, CorCr/Ti Porous and CoCr Non-Porous
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for a tibial baseplate, indicating that the device is substantially equivalent to previously marketed devices. It outlines the indications and contraindications for use, but does not include any performance metrics, study designs, or data related to acceptance criteria.
§ 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.