US-based Modern Plastics has announced that a spinal implant device using Evonik's VESTAKEEP PEEK (polyetheretherketone) has obtained 510(k) clearance from the US Food and Drug Administration (FDA).
The implant device, which exhibits superior biocompatibility and biostability, is intended for use as an intervertebral body fusion (IBF) device.
The device’s characteristics including sterilization resistance and good combination of stiffness and ductility makes it suitable for medical implant applications, claims Modern Plastics, a stocking distributor of VESTAKEEP products.
Modern Plastics president Bing Carbone said, "With 510(K) approval of the VESTAKEEP® PEEK product and inventory available in rod, resin and powder, Modern Plastics can provide technical support, fast shipping from stock inventory in Connecticut, USA, complete product traceability and detailed certification with every shipment."
Modern Plastics said there are no contractual requirements, royalties or start-up fees for purchasing VESTAKEEP PEEK.