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FDA confirmed that CeramTec’s novel ceramic total knee replacement device and proposed indication for use meet the criteria of a Breakthrough Device.
“The ceramic knee is one of the lighthouse projects in our innovation pipeline,” said Hadi Saleh, Ph.D., CEO of CeramTec. “We are diligently working on introducing this to the U.S. market in a few years so that even more joint replacement patients can benefit from the favorable characteristics of our high-performance metal-free materials.”
The goal of FDA’s Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review. Breakthrough Device designation is only awarded to breakthrough technologies that have the potential to provide more effective treatment and diagnosis for life-threatening or irreversible debilitating diseases or conditions.
