Sintx Technologies(US:SINT) Globenewswire·2025-10-20 20:14Core Insights - SINTX Technologies has received FDA approval for its SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a significant milestone for the company as it enters the U.S. market for foot and ankle reconstruction surgeries [1][2] - The company plans to launch the system in the U.S. commercial market in the first quarter of 2026, leveraging its domestic manufacturing advantages to enhance revenue growth and operational efficiency [1][2] Company Overview - SINTX Technologies is a leader in advanced ceramics, focusing on the application of silicon nitride (Si₃N₄) in the biomedical field [1][4] - The company has been a pioneer in the research and manufacturing of silicon nitride since 2008, with its products already used in human implants [4] Product Details - The SINAPTIC implant system combines proprietary silicon nitride biomaterials with a specially designed sterile single-use instrument kit, aimed at improving surgical efficiency, precision, and repeatability [2] - The system is expected to meet the growing demand for non-metal solutions in orthopedics, enhancing surgical outcomes in the foot and ankle reconstruction sector [2] Market Potential - The global foot and ankle device market is estimated to be between $4.75 billion and $5.4 billion in 2024, presenting a lucrative revenue opportunity for SINTX despite the wedge osteotomy device being a niche segment [2] - Factors such as increasing surgical volumes, the trend towards outpatient surgery centers (ASC), and the use of single-use instruments are expected to drive market growth [2]