EVONIK
PEEK medical implants receive CE mark / Titanium replacement
Two medical implant cage systems made from PEEK supplied by Evonik Industries (Darmstadt / Germany; www.evonik.com) have received CE mark certification. Evonik says it supported the manufacturer, Tria Spine (Ankara / Turkey; www.triaspine.com), in obtaining the certificate with biocompatibility studies and technical documentation on its “Vestakeep” PEEK.

“In cooperation with Evonik, we made it possible to replace titanium with the radiolucent and biocompatible PEEK,” says Ibrahim Ozgur Bektas, international sales director of Tria Spine. The products are named “LorX” PLIF Peek Cage and LorX Cervical Peek Cage with Blade. The PLIF Peek Cage is designed to provide improved stability between vertebrae, with a teeth structure that helps secure placement and prevents migration. The Cervical Peek Cage with Blade is available in various heights to restore the interbody space.

Evonik says Vestakeep PEEK has already received CE certificate and FDA 510 (K) approvals in a broad range of applications including spinal implants, suture anchors and cranial implants. The material has excellent sterilisation resistance and a good combination of stiffness and ductility, and provides a modulus of elasticity similar to that of bone, it adds.

CE marking means a product has been assessed before being placed on the market and meets EU safety, health and environmental protection requirements.
24.03.2014 Plasteurope.com [227769-0]
Published on 24.03.2014
German version...German version of this article...
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