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What is 510(K) premarketing notification for medical device knee replacements?

Medical devices come into the U.S. marketplace through FDA review.

knee implant

One process is a premarket notification clearance or 510(K) and the other is premarket approval or PMA which is more stringent.

Premarket notification obtains marketing clearance for a medical device that is "substantially equivalent" in safety and effectiveness to another lawfully marketed device or to a standard recognized by the FDA when used for the same intended purpose.

The new device must exhibit approximately the same safety and effectiveness as the "predicate" (previous) device to which the new one is being compared.

This system seems to lower standards vs. elevate them. And without any new clinical data, how can efficacy of the "improved" design be tested.

How many adverse side effect reports are required before a knee implant product is recalled?

First, in answering this, we need to begin with the premises that most adverse events are under-reported. Thus, the data tends to underestimate the true number of device-related adverse events. Because of the limitations of the existing adverse-event reporting systems, some estimate that only 1 or 2 percent of serious adverse events are reported.

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Product Identification Notice: In any of our web pages referring to Zimmer NexGen products, these pages are intended to provide information about and are referring to the same Zimmer products that were identified by Dr. Berger in his presentation and study entitled "The High Failure Rate of a High-Flex Total Knee Arthroplasty Design," and were written about in the NY Times article titled "Surgeon vs. Knee Maker: Who's Rejecting Whom?," and that are reported in the FDA MAUDE database, where reports involving the Zimmer NexGen CR Flex Cementless or Porous Femoral component can be found. Not all Zimmer NexGen products are involved in our investigations and lawsuits.