Breakthrough Device Designation Granted for Ceramic Knee Replacement

CeramTec GmbH has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its ceramic total knee replacement device.

The FDA’s Breakthrough Devices Program aims to provide patients and healthcare providers with timely access to “breakthrough” 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.
 
“The ceramic knee is one of the lighthouse projects in our innovation pipeline,” CeramTec CEO Dr. Hadi Saleh said. “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 favourable characteristics of our high-performance metal-free materials. As our footprint as a leading med-tech platform continues to grow, this is a logical next step to which we are very much looking forward. We are truly excited about this affirmation of our path.” 
 
Approximately 1 million people in the United States receive an artificial knee joint every year.
 
CeramTec is a global medtech firm with a focus on high-performance ceramics (HPC) solutions, and specializes in the development, manufacturing, and sale of parts, components, and products made from ceramic materials. With more than a century of developmental and production experience in the HPC industry, CeramTec engineers advanced ceramics for use in a wide variety of applications including critical medical applications such as hip replacements, other orthopaedic implants, dental implants and medical equipment, and industries including mobility, electronics, and also in other industrial applications. With production sites and subsidiaries in Europe, North and South America as well as Asia, CeramTec maintains its presence around the globe as a manufacturer and supplier. CeramTec is headquartered at Plochingen, near Stuttgart (Germany).