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BUSINESS • 21/10/2025 04:35 PM

SINTX Secures FDA Clearance For SINAPTIC Foot & Ankle Implant, Eyes 2026 US Launch

KUALA LUMPUR, Oct 21 (Bernama) -- SINTX Technologies Inc (SINTX), a leader in biomedical silicon nitride ceramics, announced the United States (US) Food and Drug Administration (FDA) has granted 510(k) clearance for its SINAPTIC Foot & Ankle Osteotomy Wedge System, paving the way for the company’s first commercial entry into reconstructive foot and ankle surgery in the US.

According to SINTX in a statement, a US commercial launch is targeted for the first quarter next year, leveraging SINTX’s domestic manufacturing to boost revenue growth and operational efficiency.

SINTX Chairman, President & Chief Executive Officer, Eric Olson said FDA clearance of the company’s SINAPTIC portfolio is a defining commercial milestone.

“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,” he said.

Meanwhile, its Chief Commercial Officer, Lisa Marie Del Re said: “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, bacteriostatic, hydrophilic, and enhanced visibility on imaging.

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.

-- BERNAMA

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