SINTX Technologies Receives FDA Clearance for SINAPTIC® Foot & Ankle Implant System

Core Insights - SINTX Technologies has received FDA 510(k) clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking its entry into the reconstructive foot and ankle surgery market in the U.S. with a planned commercial launch in Q1 2026 [1][3] - The global foot & ankle device market is estimated to be approximately $4.75–$5.4 billion in 2024, with SINTX targeting a significant revenue opportunity through its innovative implant system [3] Company Overview - SINTX Technologies specializes in advanced ceramics, particularly in the biomedical applications of silicon nitride (Si₃N₄), and has been a leader in this field since 2008 [5] - The SINAPTIC implant system integrates proprietary silicon nitride biomaterial with surgeon-informed designs and a sterile, single-use instrument kit to enhance surgical efficiency and outcomes [2][3] Market Positioning - The SINAPTIC system is positioned to meet the growing demand for non-metal solutions in orthopedics, aiming to improve surgical outcomes through the proven performance of silicon nitride [3] - The company anticipates that the combination of procedure growth, migration to Ambulatory Surgery Centers (ASC), and single-use instrumentation will create a compelling revenue opportunity in the foot and ankle device market [3] Product Features - The silicon nitride material used in the SINAPTIC system offers unique benefits, including superior protein absorption, osteointegration, bacteriostatic properties, hydrophilicity, and enhanced visibility in imaging compared to traditional metal implants [7]