Sintx Technologies submits FDA 510k for silicon nitride foot, ankle devices

SINTX Technologies (SINT) announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration for its novel silicon nitride osteotomy wedges-marking the official entry into the foot and ankle reconstruction market. These next-generation implants blend cutting-edge biomaterials science with surgical precision and are designed to elevate standards in orthopedic procedures. “We believe Si3N4 is the ideal orthopedic biomaterial for fusion procedures where infection risk, healing rate, and long-term stability are paramount,” said Eric Olson, CEO of SINTX Technologies.