First FDA Spinal 510(K) Clearance For Device Using Evonik’s VESTAKEEP® PEEK

In short

You may well have heard of PEEK(polyetheretherketone), which is being used in an ever increasing number of medical devices including implants where its mechanical and biocompatibility properties match the demands placed on the products. Now one manufacturer of PEEK, Evonik from Germany, is making a big noise about the fact that its proprietary VESTAKEEP® PEEK has gained an FDA clearance in the form of K7 LLC’s K7C™ Cervical Spacer, a spinal implant designed for use as an Intervertebral Body Fusion (IBF) device

Background

Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals, one derivative being its so-called VESTAKEEP® PEEK material.

This marks the first time spinal fusion device manufactured using the material has gained FDA clearance and the company is excited that it opens the door for more of its development devices to come to market.

The company claims superior biocompatibility and biostability for its VESTAKEEP® PEEK material. Its excellent sterilisation resistance and good combination of stiffness and ductility make it suitable for medical implant applications that must meet extremely high mechanical, thermal, and chemical requirements.

Company comments 

Michael Smith, founder and CEO of K7 LLC attributed VESTAKEEP® PEEK’s durability as a key component in gaining FDA 510(k) clearance. “We could not be more pleased with the test results and material durability of VESTAKEEP® PEEK,” said Smith. “The inherent strength and added ductility have created new possibilities for our PEEK implant designs.”

“Creating innovative solutions for our customers is a core component of Evonik,” said Sanjeev Taneja, vice president of Evonik’s High Temperature Polymers Business. “The FDA approval is a testament to the product quality of VESTAKEEP® PEEK and the strength of its MAF. It is also an example of the long-term commitment Evonik has in the medical device and orthopedic industries. This approval validates Evonik as a true player in the implant PEEK market.”

“Significant investments and thorough material testing have been completed on the VESTAKEEP® PEEK product line to ensure Masterfile strength and preparedness,” said Kenneth Ross, Evonik’s VESTAKEEP® medical business development manager in North & South America. “We know VESTAKEEP® PEEK will serve as an outstanding medical material driving innovation in new product ideas and metal replacement developments.”

Regulatory status

The VESTAKEEP® PEEK iGrade material also has regulatory clearance for spinal implants in Europe and Asia. With this 510(K) approval, customers will now have easier access to regulatory approvals in the United States market.

Source: Evonik, Business Wire