Sintx Technologies Wins US FDA 510(k) Clearance For The SINAPTIC Foot & Ankle Osteotomy Wedge System

(RTTNews) - Sintx Technologies, Inc. (SINT), Monday announced it has secured the U.S. Food and Drug Administration 510(k) clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System, paving its way into the billion-dollar reconstructive foot and ankle surgery market.

The system, which integrates SINTX's proprietary silicon nitride biomaterial with surgeon-informed implant designs and a single-use instrument kit, is expected to be commercially available in the U.S. market in the first quarter of 2026.

CEO Eric Olson, Chairman commented, "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."

In the pre-market hours, SINT is trading at $4.08, up 3.53 percent on the Nasdaq.