Surface Dynamics, an orthopedic implant coater company, validated Evonik's VESTAKEEP polymer for the titanium coating processes.
Here are five observations:
1. Evonik's PEEK polymer demonstrated the critical mechanical properties required under the FDA consensus standards.
2. Coatings were applied to a large quantity of test pieces that were then exposed to a series of required tests from the American Society for Testing Materials.
3. This validation was required in order for Surface Dynamics to include the. PEEK polymer into its master file that resides with the FDA.
4. Medical companies submitting their devices to the FDA for review using Surface Dynamics coating on Evonik's VESTAKEEP will have to perform required tests on their specific device.
5. Evonik is a German industrial group focusing on specialty chemicals.