Sintx receives FDA clearance for SINAPTIC Foot, Ankle implant system

SINTX Technologies (SINT) announced U.S. Food and Drug Administration, FDA, 510(k) clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System, enabling SINTX’s commercial entry into reconstructive foot and ankle surgery in the United States. SINTX plans a U.S. commercial launch in Q1 2026. “Orthopedics is evolving beyond traditional materials,” said Lisa Marie Del Re, Chief Commercial Officer. “With growing demand for non-metal solutions, the SINAPTIC system delivers the proven performance of silicon nitride to foot and ankle reconstruction-elevating expectations for surgical outcomes.”