The U.S. Food and Drug Administration has approved the first-ever spinal column implant made of Vestakeep polyethetherketone (PEEK).
Evonik announced that the associated pre-market notification 510(k) has been successfully issued, simplifying the process for future medical device manufacturers to get approval.
The FDA green light follows an intensifying effort by Evonik to penetrate medical markets with its engineering materials. Its PEEK medial plastics have already been approved for direct contact with the human body, for both short-term applications and in long-term implants in Europe and Asia, which have less demanding approval processes than the United States.
Evonik says the pitch for its PEEK is its biocompatible and biostable coupled with good processability for both injection molding and machining.