K7 LLC’s K7C Cervical Spacer, a spinal implant device using Evonik’s Vestakeep PEEK (polyetheretherketone), has received FDA 510(k) approval for use as an intervertebral body fusion device.
According to an Evonik’s press release, this marks the first time a Vestakeep PEEK-based spinal fusion medical device has gained 510(k) approval from the FDA. It added that the K7C cervical spacer is one of several PEEK-based spinal implant devices being developed by K7 LLC.
Michael Smith, founder and chief executive officer of K7 LLC attributed Vestakeep PEEK’s durability as a key component in gaining FDA 510(k) clearance. He said: “We could not be more pleased with the test results and material durability of Vestakeep PEEK. 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 masterfiles. It is also an example of the long-term commitment Evonik has in the medical device and orthopaedic industries.”
The press release reported that Vestakeep PEEK is known for its superior biocompatibility and biostability. It added that 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.
The Vestakeep PEEK iGrade material also has regulatory clearance for spinal implants in Europe and Asia.