The spinal implant device, called K7C Cervical Spacer, which uses Evonik Corporation’s Vestakeep PEEK (polyether ether ketone), has received the FDA’s 510(k) clearance for use as an intervertebral body fusion (IBF) device.
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.”
He noted that this is the first time a Vestakeep PEEK-based spinal fusion medical device has received 510(k) clearance from the FDA. The K7C Cervical Spacer is one of several PEEK-based spinal implant devices being developed by K7 LLC.
“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 an example of the long-term commitment Evonik has to the medical device and orthopedic industries. This approval validates Evonik as a true player in the implant PEEK market.”
Taneja said that Evonik’s customers are welcome to reference the Vestakeep PEEK product line Masterfiles (MAF). These are documents containing comprehensive test data on the product’s mechanical and biocompatible properties that meet FDA regulatory requirements, which could be helpful in guiding future registration processes for implant medical devices.
