Sintx Technologies (SINT) FDA Approvals $1.56 -0.16 (-9.30%) Closing price 07/13/2026 04:00 PM EasternExtended Trading$1.49 -0.07 (-4.23%) As of 04:01 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsTrendsBuy This Stock Sintx Technologies' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Sintx Technologies (SINT). Over the past two years, Sintx Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SINAPTIC. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. SINAPTIC FDA Regulatory Events SINAPTIC is a drug developed by Sintx Technologies for the following indication: Foot & Ankle Osteotomy Wedge System. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Provided Update - March 19,2026Provided Update Drug: SINAPTICAnnounced Date: March 19, 2026Indication: Foot & Ankle Osteotomy Wedge SystemAnnouncementSINTX Technologies, Inc. announced the successful completion of the first-in-human surgical procedure utilizing its FDA-cleared SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a major clinical and commercial milestone in the Company's expansion into the global orthopedic device market.AI SummarySINTX Technologies announced the successful completion of the first-in-human surgical use of its FDA-cleared SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a major clinical and commercial milestone as the company expands into the global foot and ankle reconstruction market. The procedure was performed March 13, 2026 by Dr. Scott Carrington, DPM, FACFAS, at Emplify Health in La Crosse, Wisconsin. Surgeons reported the implant provided the needed structural integrity and clear imaging crucial for reconstructive cases. The SINAPTIC wedge uses SINTX’s silicon nitride biomaterial, noted for osteoconductive and pro-osteogenic properties, a bacteriostatic surface, hydrophilicity, and compatibility with X-ray, CT, and MRI. These features may help bone integration, reduce bacterial adhesion, and improve post-operative imaging, potentially aiding clinical decision-making and patient recovery. SINTX views this case as an important step toward commercial adoption of the SINAPTIC platform, broader orthopedic applications beyond spine, and a planned U.S. commercial launch to support long-term growth. Read AnnouncementProvided Update - October 20,2025Provided Update Drug: SINAPTICAnnounced Date: October 20, 2025Indication: Foot & Ankle Osteotomy Wedge SystemAnnouncementSINTX Technologies, Inc. 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.AI SummarySINTX Technologies announced U.S. Food and Drug Administration 510(k) clearance for its SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking the company’s entry into reconstructive foot and ankle surgery in the United States. The implant combines SINTX’s proprietary silicon nitride biomaterial with surgeon-informed designs and a sterile, single-use instrument kit engineered to enhance surgical efficiency, precision and reproducibility. By blending advanced material science with practical innovation, SINAPTIC aims to address unmet clinical needs in foot and ankle procedures and support long-term company growth. SINTX plans a U.S. commercial launch in Q1 2026, leveraging its U.S.-based manufacturing to accelerate revenue and improve operating efficiency. The non-metal, pro-osteogenic and bacteriostatic properties of silicon nitride also offer better bone integration and clear imaging on X-rays and CT scans. Targeting a multibillion-dollar market, SINTX expects the new system to drive meaningful clinical impact and create shareholder value as part of its broader biomaterials platform strategy.Read Announcement Sintx Technologies FDA Events - Frequently Asked Questions Has Sintx Technologies received FDA approval? As of now, Sintx Technologies (SINT) has not received any FDA approvals for its therapy in the last two years. What drugs has Sintx Technologies submitted to the FDA? In the past two years, Sintx Technologies (SINT) has reported FDA regulatory activity for SINAPTIC. What is the most recent FDA event for Sintx Technologies? The most recent FDA-related event for Sintx Technologies occurred on March 19, 2026, involving SINAPTIC. The update was categorized as "Provided Update," with the company reporting: "SINTX Technologies, Inc. announced the successful completion of the first-in-human surgical procedure utilizing its FDA-cleared SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a major clinical and commercial milestone in the Company's expansion into the global orthopedic device market." What conditions do Sintx Technologies' current drugs treat? Currently, Sintx Technologies has one therapy (SINAPTIC) targeting the following condition: Foot & Ankle Osteotomy Wedge System. 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Provided Update - March 19,2026Provided Update Drug: SINAPTICAnnounced Date: March 19, 2026Indication: Foot & Ankle Osteotomy Wedge SystemAnnouncementSINTX Technologies, Inc. announced the successful completion of the first-in-human surgical procedure utilizing its FDA-cleared SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a major clinical and commercial milestone in the Company's expansion into the global orthopedic device market.AI SummarySINTX Technologies announced the successful completion of the first-in-human surgical use of its FDA-cleared SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a major clinical and commercial milestone as the company expands into the global foot and ankle reconstruction market. The procedure was performed March 13, 2026 by Dr. Scott Carrington, DPM, FACFAS, at Emplify Health in La Crosse, Wisconsin. Surgeons reported the implant provided the needed structural integrity and clear imaging crucial for reconstructive cases. The SINAPTIC wedge uses SINTX’s silicon nitride biomaterial, noted for osteoconductive and pro-osteogenic properties, a bacteriostatic surface, hydrophilicity, and compatibility with X-ray, CT, and MRI. These features may help bone integration, reduce bacterial adhesion, and improve post-operative imaging, potentially aiding clinical decision-making and patient recovery. SINTX views this case as an important step toward commercial adoption of the SINAPTIC platform, broader orthopedic applications beyond spine, and a planned U.S. commercial launch to support long-term growth. Read Announcement
Provided Update - October 20,2025Provided Update Drug: SINAPTICAnnounced Date: October 20, 2025Indication: Foot & Ankle Osteotomy Wedge SystemAnnouncementSINTX Technologies, Inc. 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.AI SummarySINTX Technologies announced U.S. Food and Drug Administration 510(k) clearance for its SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking the company’s entry into reconstructive foot and ankle surgery in the United States. The implant combines SINTX’s proprietary silicon nitride biomaterial with surgeon-informed designs and a sterile, single-use instrument kit engineered to enhance surgical efficiency, precision and reproducibility. By blending advanced material science with practical innovation, SINAPTIC aims to address unmet clinical needs in foot and ankle procedures and support long-term company growth. SINTX plans a U.S. commercial launch in Q1 2026, leveraging its U.S.-based manufacturing to accelerate revenue and improve operating efficiency. The non-metal, pro-osteogenic and bacteriostatic properties of silicon nitride also offer better bone integration and clear imaging on X-rays and CT scans. Targeting a multibillion-dollar market, SINTX expects the new system to drive meaningful clinical impact and create shareholder value as part of its broader biomaterials platform strategy.Read Announcement
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