DiFusion Technologies has received the US Food and Drug Administration's (FDA) approval for its Vestakeep Peek-based Xiphos ALIF (polyetheretherketone) spinal implant for use in Interbody Fusion (IBF) devices.
Evonik’s Vestakeep Peek is characterized by its biocompatibility and biostability in the development of medical devices as a raw material.
DiFusion Technologies managing director Derrick Johns said that the company is excited about the FDA 510(k) approval of the Vestakeep Peek-based Xiphos ALIF spinal implant.
"This milestone helps pave the way for more innovative medical devices developed from bioactive polymers," Johns added.
Vestakeep Peek is used in spinal implants that meet high mechanical, thermal, and chemical requirements.
Evonik High Temperature Polymers Business vice president Sanjeev Taneja said that the company strives to meet the needs of its customers and helping DiFusion achieve FDA 510(k) approval for Xiphos ALIF is an example of its efforts.
"This marks the second product line DiFusion is using VESTAKEEP PEEK for and demonstrates the strong relationships necessary for success in this space," Taneja added.