SINTX Technologies Inc. is entering the U.S. lower extremities market with the U.S. Food and Drug Administration (FDA) 510(k) clearance of its SINAPTIC Foot & Ankle Osteotomy Wedge System. The company plans to launch the product in the first quarter next 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 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,” SINTX Chief Commercial Officer Lisa Marie Del Re stated. “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 SINTX’s silicon nitride material claims 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 computed tomography scans.

“FDA clearance of our SINAPTIC portfolio is a defining commercial milestone for the company,” SINTX Chairman/President/CEO Eric Olson 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.”

Industry estimates place the global foot and ankle device market at approximately $4.75 billion to $5.4 billion in 2024. While osteotomy wedges represent a subset of this category, SINTX is confident that procedure growth, ASC migration, and workflow-enhancing single-use instrumentation will together create a compelling revenue opportunity.

Located in Salt Lake City, Utah, SINTX Technologies is a ceramics company that develops and commercializes materials, components, and technologies for medical and other high-value applications. SINTX researches, develops, and manufactures silicon nitride (Si₃N₄), and its products have been implanted in humans since 2008.