Select Page

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

Fluorescent Markers Could Jumpstart U.K. Recycling

A new technique using invisible tags to label plastic packaging could jumpstart a “quantum leap” in U.K. recycling. The advance switches up sorting by adding phosphors, the

Read More

Cartilage-Like Hydrogel Promises 3D-Printable Knee Implants

Far more than a simple hinge, the human knee is a complex, intricate mechanism, and a knee injury is a painful and debilitating of condition that’s difficult and

Read More

The Forecast for Global Bioplastics

The global bioplastics for packaging industry is forecast to grow from 2017 to 2022 at an annual average rate of 17% to a market value of almost $7.2 billion according to

Read More

Lomont Molding Acquires R&D Molders

Lomont Molding LLC (Mt. Pleasant, IA) reports that it has acquired R&D Molders of Georgetown, TX. – “This acquisition merges two highly compatible manufacturing

Read More

IPL Lands a Major Contract for Organic Carts With the City of Calgary

IPL Inc., a North American producers of injection-molded plastic products, has announced that it has won a major contract for providing organic wheeled carts to The

Read More

LANXESS Successfully Completes Acquisition of Chemtura

Specialty chemicals company LANXESS has successfully completed the acquisition of U.S. company Chemtura, one of the world’s leading suppliers of flame retardant

Read More

Diab Signs Long-Term Contract With Diehl Aircabin

Diab has signed a long term contract with Diehl Aircabin to supply its Divinycell F foam core for cabin applications. The company says that Divinycell F can minimize the

Read More

New Joint Venture Advances Applications for Composites

Titan Advanced Composites (Gastonia, NC), a new joint venture between Asbury Graphite Mills and ZePR, was recently formed to address the challenges of composite materials

Read More

Stratasys Launches Carbon Fiber-Filled Nylon for 3D Printing

3D printing specialist Stratasys has developed FDM Nylon 12CF, a carbon fiber-filled thermoplastic which could replace metal components in a range of applications.

Read More

Meusburger Expands Range of Tunnel Gate Inserts

Moldmakers can save time and money from design to manufacturing with the use of tunnel gate inserts, according to Meusburger (Wolfurt, Austria). The company has

Read More