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SINTX Technologies announced 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 1Q26. The announcement follows confirmation of SINTX’s acquisition of SiNAPTIC earlier this year.
The SINAPTIC implant system combines SINTX’s proprietary silicon nitride biomaterial with surgeon-informed implant designs and a planned sterile, single-use instrument kit.
“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.”
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.
Eric Olson, Chairman, President & CEO, said, “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.”
Source: SINTX Technologies, Inc.
