SINTX Technologies Receives FDA Clearance for SINAPTIC® Foot & Ankle Implant System
FDA cleared and U.S. manufactured implant system positions SINTX to enter billion-dollar U.S. market SALT LAKE CITY, Utah, Oct. 20, 2025 (GLOBE NEWSWIRE) — 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 & 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, leveraging its U.S.-based manufacturing to drive revenue acceleration and operating efficiency. The SINAPTIC implant system combines SINTX’s proprietary silicon nitride biomaterial with surgeon-informed implant designs and 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. “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.” As cleared under the FDA submission, some of the material claims of SINTX’s silicon nitride relevant to the device include: Pro-osteogenic: Unique surface chemistry mechanisms have demonstrated superior protein absorption and osteointegration when compared to traditional biomaterials. Bacteriostatic: Surface properties have been shown to actively repel and/or inhibit the growth of various types of bacteria in a laboratory and animal studies. Hydrophilic: Attracts fluids, further deterring bacteria colonization and enhancing bone-building mechanisms. Enhanced visibility on imaging: Unlike metal implants, silicon nitride allows for clear visualization of the surrounding tissues in X-rays and CT scans. “FDA clearance of