Medical device FDA 510K clearances surpass 80 with VESTAKEEP® PEEK
Evonik Corporation’s VESTAKEEP® PEEK, used by medical device customers for the design and development of surgical implants, recently surpassed a milestone of more than 80 devices cleared by the U.S. Food and Drug Administration (FDA).
Medical OEM’s usually take one of two paths to have their devices reviewed and approved or ‘cleared’ by the FDA to be implanted in the body. One is a Premarket Approval (PMA) which is the most stringent process the FDA has, often requiring years of testing and clinical trials to prove the implant has sufficient safety and effectiveness for the intended use. The other is the Premarket Notification, or 510K process, that is most common and desired. This process typically takes 90 days or less and references a predicate device already cleared in the market by the FDA. Though VESTAKEEP® PEEK has over 80 customer devices cleared under the 510K process, it has also been used in devices approved under the more stringent PMA process, demonstrating that it is an outstanding material for even the most challenging application designs.
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