Evonik's VESTAKEEP® polyetheretherketone has achieved a milestone: more than 80 devices using VESTAKEEP® polyetheretherketone have been approved by the US Food and Drug Administration (FDA).
Its polyetheretherketone is used by medical device customers to design and develop surgical implants. Medical original equipment manufacturers (OEMs) usually get their implants tested by the FDA in two ways. One is pre-sale permission (PMA). This is the FDA's most stringent process and often requires years of testing and clinical trials to verify the safety and effectiveness of the implant. The other is the pre-sale notification, also known as the 510K process, which is the most common and popular method. This process takes a reference to a device that has been approved by the FDA and typically takes 90 days or less.
VESTAKEEP® polyetheretherketone has more than 80 customer devices that pass the 510K process, and there are also devices using VESTAKEEP® polyetheretherketone that pass the more stringent PMA process, which fully demonstrates that this is a comparison with the most demanding application requirements Also considered outstanding material.
Evonik's VESTAKEEP® polyetheretherketone was developed to meet the needs of the medical device industry for high-performance biocompatible materials. VESTAKEEP®'s high fatigue resistance and hardness are the keys to the successful development of these medical devices, enabling them to withstand high loads during surgery and subsequent healing.
As the darling of the medical device industry, Evonik's VESTAKEEP® polyetheretherketone is used in the development of medical devices and technologies for the plastic surgery, spine, sports medicine, cardiovascular, limb, craniofacial, dental, and oncology markets. "Achieving this milestone with our customers is a testament to the acceptance and growth of VESTAKEEP® in the medical market," said Vikram Chatur, Vice President and General Manager of Evonik Performance Polymers.
"Because Evonik's focus on the medical device industry has such results today, our strength is research and development and innovation. We will continue to develop the VESTAKEEP® series to increase our business scope and enhance polyetheretherketone polymer technology to improve worldwide. Medical quality. "