SINTX Technologies Receives FDA Clearance for SINAPTIC® Foot & Ankle Implant System
SiNtx Technologies, Inc. (SINT)
Company Research
Source: GlobeNewswire
FDA cleared and U.S. manufactured implant system positions SINTX to enter billion-dollar U.S. market SALT LAKE CITY, Utah, Oct. 20, 2025 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”), a leader in advanced ceramics specializing in biomedical applications of silicon nitride (Si3N4), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, enabling SINTX’s commercial entry into reconstructive foot and ankle surgery in the United States. SINTX plans a U.S. commercial launch in Q1 2026, leveraging its U.S.-based manufacturing to drive revenue acceleration and operating efficiency. 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 prac
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News
- SINTX Technologies Signs Supply Agreement with EVONIK to Manufacture Silicon Nitride–PEEK Compound for AI-Assisted, 3D-Printed Patient-Specific Implants [Yahoo! Finance]Yahoo! Finance
- SINTX Technologies Signs Supply Agreement with EVONIK to Manufacture Silicon Nitride–PEEK Compound for AI-Assisted, 3D-Printed Patient-Specific ImplantsGlobeNewswire
- Sintx Technologies GAAP EPS of -$3.46 misses by $2.95, revenue of $0.21M misses by $0.09M [Seeking Alpha]Seeking Alpha
- SINTX Reports Pivotal Third Quarter Business Update and Financial Highlights Driven by FDA Clearance, Product and IP Portfolio Expansions and Increased Operational Efficiencies [Yahoo! Finance]Yahoo! Finance
- SINTX Reports Pivotal Third Quarter Business Update and Financial Highlights Driven by FDA Clearance, Product and IP Portfolio Expansions and Increased Operational EfficienciesGlobeNewswire
SINT
Analyst Actions
- 9/22/25 - Ascendiant Capital
SINT
Sec Filings
- 12/1/25 - Form 8-K
- 11/14/25 - Form SCHEDULE
- 11/14/25 - Form SCHEDULE
- SINT's page on the SEC website