(277 days)
The Fenning-Pappas, Modular Knee Bearing is intended for reconstruction or revision of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis, in knees having coirectable mity, and viable or reconstructable ligaments. valgus or var ..
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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a medical device called "Fenning-Pappas, Modular Knee Bearing", indicating it has been found substantially equivalent to a legally marketed predicate device.
The letter discusses regulatory classifications, general controls, and other administrative information related to marketing the device. It also includes the "Indications for Use" for the device, but it does not detail any performance metrics, study results, or acceptance criteria.
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§ 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.