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SINTX Technologies Receives FDA 510(K) Clearance For Its SINAPTIC Foot & Ankle Osteotomy Wedge System

Benzinga·11/13/2025 13:08:13
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SALT LAKE CITY, Utah, Nov. 13, 2025 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ:SINT) ("SINTX" or the "Company"), an advanced ceramics and biomaterials company focused on silicon-nitride–based medical technologies, today provided a business update reporting third quarter financial results in conjunction with the filing the Company's Form 10-Q for the quarter ended September 30, 2025.

During the third quarter and subsequent weeks, SINTX advanced a focused commercialization plan centered on infection-resistant silicon nitride devices and polymer composites, while tightening its operating footprint and strengthening its balance sheet.

Business Highlights and Key Milestones

  • FDA 510(k) Clearance: Received U.S. FDA clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, enabling SINTX's commercial entry into reconstructive foot and ankle surgery in the U.S.