SINTX receives FDA 510(k) clearance for silicon nitride implant system

SINTX Technologies, Inc, headquartered in Salt Lake City, Utah, USA, has received 501(k) clearance from the US Food and Drug Administration (FDA) for its SINAPTIC Foot & Ankle Osteotomy Wedge System, following SINTX’s recent acquisition of SiNAPTIC Surgical. The system is planned for a Q1 2026 commercial launch.

The SINAPTIC implant system combines SINTX’s proprietary silicon nitride biomaterial with surgeon-informed implant designs and a planned sterile, single-use instrument kit intended to enhance surgical efficiency, precision and reproducibility.

“Orthopaedics is evolving beyond traditional materials,” stated 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 clarified under the FDA submission, SINTX’s silicon nitride is said to be pro-osteogenic, bacteriostatic, hydrophilic and offer enhanced visibility on imaging compared to metal components. The material’s unique surface chemistry mechanisms are said to have demonstrated superior protein absorption and osteointegration when compared to traditional biomaterials. These surface properties have also been shown to actively repel or inhibit the growth of bacteria in both laboratory and animal studies. As a hydrophilic material, it attracts fluids, which further deters bacterial colonisation and enhances bone-building mechanisms.

“FDA clearance of our SINAPTIC portfolio is a defining commercial milestone for the company,” stated Eric Olson, chairman, president & CEO. “By entering the high-value, procedure-driven market with a differentiated biomaterial and surgeon-validated designs, we expect to generate meaningful clinical impact and build shareholder value as we execute our commercial strategy.”

www.sintx.com