Kuala lumpur: SINTX Technologies, Inc. (NASDAQ: SINT) (‘SINTX’ or the ‘Company’), a leader in advanced ceramics specializing in biomedical applications of silicon nitride (Si3N4), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the SINAPTIC® Foot and Ankle Osteotomy Wedge System. This development marks SINTX’s commercial entry into reconstructive foot and ankle surgery in the United States. The company plans a U.S. commercial launch in the first quarter of 2026, utilizing its U.S.-based manufacturing to drive revenue acceleration and operational efficiency.

According to BERNAMA News Agency, the SINAPTIC implant system integrates SINTX’s proprietary silicon nitride biomaterial with surgeon-informed implant designs. It includes a planned sterile, single-use instrument kit engineered to enhance surgical efficiency, precision, and reproducibility. By combining differentiated material science with practical surgical innovation, the SINAPTIC implant system exemplifies SINTX’s strategy to leverage its unique biomaterials platform into scalable, high-value medical solutions that address unmet clinical needs and drive long-term growth.