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

Core Insights - Sintx Technologies, Inc. has received FDA 510(k) clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System, allowing entry into the billion-dollar reconstructive foot and ankle surgery market [1][2] - The system combines SINTX's proprietary silicon nitride biomaterial with surgeon-informed implant designs and a single-use instrument kit, expected to be available in the U.S. market by Q1 2026 [1] Company Strategy - CEO Eric Olson emphasized the potential for meaningful clinical impact and shareholder value through the differentiated biomaterial and surgeon-validated designs in a high-value, procedure-driven market [2] - The stock is currently trading at $4.08, reflecting a 3.53% increase in pre-market hours on the Nasdaq [2]