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

Tedder Industries Expands Capabilities With Wittmann Battenfeld Machines

Tedder Industries (Coeur d’Alene, Idaho) was founded in 2010 by Thomas Tedder to manufacture firearm accessories, such as gun belts

Read More

McClarin Acquires Composites Company

McClarin Plastics, a manufacturer of thermoformed plastic, glass fiber reinforced plastic and composite products has acquired Custom

Read More

Toward a Broader View of the New Plastics Economy

America’s plastics makers welcome efforts to promote innovation and advance the sustainability of plastics, such as the Ellen MacArthur

Read More

PPG Recognized as One of US Best Large Employers

Coating specialist PPG says that has been named one of America’s best large employers, according to a list published by Forbes magazine.

Read More

CARE Names Person and Recycler of the Year

Carpet America Recovery Effort (CARE), a Dalton, Georgia-based nonprofit organization charged with advancing market-based solutions

Read More

The Poultry Industry to Pack Their Products With Biodegradable Plastics Obtained From Feathers

The European project KARMA 2020, where Aimplas participates, will develop a waste valorization technology in the poultry industry to

Read More

Sleeve Label Award Winners Show Ingenuity in Capturing Consumer Attention

“There seems to be no end to the creativity, technological advancement and ‘on-shelf’ ability to capture the attention of consumers that sleeve labeling is bringing to the packaging industry—and the winning entries in this year’s AWA Sleeve Label Awards certainly...
Read More

Sensor-Embedded Plastic Wrap Makes Brain Surgery Safer

It almost goes without saying that brain surgery requires extreme precision, but there hasn’t been much advancement in brain mapping

Read More

Borealis to Build Dedicated Automotive Compounding Plant in North America

Borealis, a leading provider of innovative solutions in the fields of polyolefins, base chemicals and fertilizers, has decided to build a dedicated

Read More

IPL Buys California-Based Molder Macro Plastics

In a bid to expand its footprint in the U.S. market and the growing South American market, Quebec-based injection molder IPL Inc. has purchased

Read More