PlasticsEdge™ Lead Generation Program: Call 978-342-9000 for details or email [email protected]

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.

plastics daily news

Related Posts

Italian PVC Film Manufacturer Forms Alfatherm North America Inc.

Alfatherm SpA (Venegono, Italy), one of Europe’s major producers of rigid, semi-rigid and plasticized furniture PVC foils, announced the formation

Read More

LyondellBasell Begins Production at New PP Compounding Plant in Dalian, China

LyondellBasell, one of the largest plastics, chemicals and refining companies in the world, today announced the successful startup of a new 20

Read More

Progressive Components Introduces ModuLifter Undercut Release System

Progressive Components (Wauconda, IL) has introduced the ModuLifter Undercut Release System that simplifies the release of undercuts for

Read More

Burgmann Starts Braiding Production

Burgmann Packings Composites, based in Ireland, has launched a new robot handling system for over-braiding a range of mandrels and cores.

Read More

Plastics Machinery Shipments up in Q2 2017: Report

North American shipments of plastics machinery registered a year-over-year (y/y) gain in Q2 of 2017, reversing a trend of three consecutive

Read More

Automotive Accessories Maker Wins Patent and Trademark Infringement Suit Against Chinese Companies

On Nov. 7, 2016, I wrote an article about how trade shows are excellent places to find your knocked-off products. The company I wrote about

Read More

Don’t Follow Kenya’s Example on Plastic Bags

The idea of the United States taking environmental cues from Kenya, a country that ranks near the bottom for environmental performance,

Read More

Clariant, Huntsman Reject Call to Cancel Their Merger

Swiss chemical maker Clariant AG and U.S.-based Huntsman Corporation have reconfirmed their intention to merge in replying to an open

Read More

Victrex CEO Retires

Dave Hummel has retired as CEO of polyaryletherketone (PAEK) composite manufacturer Victrex after 24 years as CEO. He is replaced by

Read More

ISRI Seeks Input for REMADE Institute Efforts

The Institute of Scrap Recycling Industries (ISRI), Washington, has announced it is seeking input from industry professionals on current technical and

Read More