SINTX Technologies Receives FDA Clearance for SINAPTIC® Foot & Ankle Implant System
SINTX (NASDAQ: SINT) received FDA 510(k) clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System on October 20, 2025, enabling commercial entry into U.S. reconstructive foot and ankle surgery.
The company plans a U.S. launch in Q1 2026, will leverage U.S.-based manufacturing, and highlights silicon nitride properties including pro-osteogenic effects, bacteriostatic surface behavior (laboratory and animal studies), hydrophilicity, and improved imaging visibility. Industry estimates place the global foot & ankle device market at $4.75–$5.4 billion (2024).
SINTX (NASDAQ: SINT) ha ricevuto l’autorizzazione FDA 510(k) per SINAPTIC Foot & Ankle Osteotomy Wedge System il 20 ottobre 2025, permettendo l’ingresso commerciale nella chirurgia ricostruttiva del piede e della caviglia negli USA.
L’azienda prevede un lancio negli USA nel Q1 2026, sfrutterà la produzione basata negli Stati Uniti e mette in evidenza le proprietà del nitruro di silicio, tra cui effetti pro-osteogenici, comportamento della superficie bacteriostatica (studi di laboratorio e su animali), idrofilia e migliore visibilità di imaging. Le stime del settore collocano il mercato globale di dispositivi per piede e caviglia a circa 4,75–4,4 miliardi di dollari (2024).
SINTX (NASDAQ: SINT) recibió la aprobación 510(k) de la FDA para el SINAPTIC Foot & Ankle Osteotomy Wedge System el 20 de octubre de 2025, permitiendo la entrada comercial en la cirugía reconstructiva del pie y tobillo en Estados Unidos.
La empresa planea un lanzamiento en EE. UU. en el primer trimestre de 2026, aprovechará la fabricación con sede en EE. UU. y destaca las propiedades del nitruro de silicio, incluyendo efectos pro-osteogénicos, comportamiento bacteriostático de la superficie (estudios de laboratorio y animales), hidrofilia y una mejor visibilidad de imagen. Las estimaciones de la industria sitúan el mercado global de dispositivos para pie y tobillo en 4,75–4 mil millones de dólares (2024).
SINTX(NASDAQ: SINT)은 SINAPTIC Foot & Ankle Osteotomy Wedge System에 대한 FDA 510(k) 승인을 2025년 10월 20일에 받았으며, 미국의 재건 발 및 발목 수술에 상용 진입을 가능하게 합니다.
회사는 미국 내 출시를 2026년 1분기에 계획하고 있으며 미국 내 제조를 활용하고 실리콘 질화물의 특성으로 골형성 촉진 효과, 표면의 살생물성(실험실 및 동물 연구), 친수성 및 향상된 영상 가시성을 강조합니다. 업계 추정에 따르면 발 및 발목 기기 글로벌 시장은 2024년 기준 47.5억~54억 달러로 추정됩니다.
SINTX (NASDAQ : SINT) a obtenu l’autorisation FDA 510(k) pour le SINAPTIC Foot & Ankle Osteotomy Wedge System le 20 octobre 2025, ce qui permet l’entrée commerciale dans la chirurgie reconstructive du pied et de la cheville aux États-Unis.
L’entreprise prévoit un lancement américain au premier trimestre 2026, s’appuiera sur une fabrication basée aux États-Unis et met en avant les propriétés du nitrure de silicium, notamment les effets pro-ostéogènes, le comportement bactériostatique de la surface (études en laboratoire et animales), l’hydrophilie et une meilleure visibilité d’imagerie. Les estimations de l’industrie situent le marché mondial des dispositifs pied et cheville à environ 4,75–5,4 milliards de dollars (2024).
SINTX (NASDAQ: SINT) erhielt die FDA 510(k)-Freigabe für das SINAPTIC Foot & Ankle Osteotomy Wedge System am 20. Oktober 2025, was den kommerziellen Einstieg in die rekonstruktive Fuß- und Sprunggelenk-Chirurgie in den USA ermöglicht.
Das Unternehmen plant einen US-Start im Q1 2026, wird auf US-amerikanische Fertigung setzen und hebt Eigenschaften von Siliziumnitrid hervor, darunter pro-osteogene Effekte, bakteriostatisches Oberflächenverhalten (Labor- und Tier-Studien), Hydrophilie und verbesserte Bildgebung. Branchenprognosen setzen den weltweiten Markt für Fuß- und Sprunggelenkgeräte im Jahr 2024 auf etwa 4,75–5,4 Milliarden USD.
حصلت SINTX (بورصة ناسداك: SINT) على موافقات FDA 510(k) لـ SINAPTIC Foot & Ankle Osteotomy Wedge System في 20 أكتوبر 2025، مما يتيح الدخول التجاري في جراحة إعادة البناء للقدم والكاحل في الولايات المتحدة.
تخطّط الشركة لإطلاق في الولايات المتحدة في الربع الأول من 2026، ستعتمد على التصنيع في الولايات المتحدة، وتسلط الضوء على خصائص نيتريد السيليكون بما في ذلك تأثيرات داعمة للعِظام، وسلوك سطح مقاوم للبكتيريا (دراسات مخبرية وحيوانية)، والخصائص الرطوبية وتحسين وضوح التصوير. وتشير تقديرات الصناعة إلى أن السوق العالمي لأجهزة القدم والكاحل يقدر بنحو 4,75–5,4 مليار دولار (2024).
SINTX（纳斯达克股票代码：SINT）于2025年10月20日获得FDA 510(k)批准，允许SINAPTIC Foot & Ankle Osteotomy Wedge System在美国进入商业化，用于足踝重建手术。
公司计划在2026 年第一季度在美国上市，将利用美国本土制造，并强调硅氮化物属性，包括促进成骨的作用、表面抗菌特性（实验室与动物研究）、亲水性及改进的成像可见性。行业估计全球足踝器械市场在2024年约为 47.5 亿到 54 亿美元。
- FDA 510(k) clearance received on October 20, 2025
- Planned U.S. commercial launch in Q1 2026
- U.S.-based manufacturing to support revenue acceleration
- Silicon nitride offers enhanced imaging visibility versus metal
- Osteotomy wedges are a subset of the $4.75–$5.4B foot & ankle market
- Material performance claims rely on laboratory and animal studies, not reported human trial data
Insights
FDA 510(k) clearance plus U.S. manufacturing enables SINTX to commercialize a silicon nitride foot and ankle implant in the U.S.
SINTX gains regulatory clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System via an FDA 510(k) on
The device’s cleared material claims include pro-osteogenic, bacteriostatic, hydrophilic surface properties, and enhanced imaging visibility. These technical claims, combined with surgeon-informed designs, form the product’s value proposition. Key dependencies and risks include successful execution of the planned
Concrete items to watch: market uptake after the
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 practical surgical innovation, the SINAPTIC implant system exemplifies SINTX’s strategy to leverage its unique biomaterials platform into scalable, high-value medical solutions that address unmet clinical needs and drive long-term growth.
“Orthopedics is evolving beyond traditional materials,” said Lisa Marie Del Re, Chief Commercial Officer. “With growing demand for non-metal solutions, the SINAPTIC system delivers the proven performance of silicon nitride to foot and ankle reconstruction—elevating expectations for surgical outcomes.”
As cleared under the FDA submission, some of the material claims of SINTX’s silicon nitride relevant to the device include:
- Pro-osteogenic: Unique surface chemistry mechanisms have demonstrated superior protein absorption and osteointegration when compared to traditional biomaterials.
- Bacteriostatic: Surface properties have been shown to actively repel and/or inhibit the growth of various types of bacteria in a laboratory and animal studies.
- Hydrophilic: Attracts fluids, further deterring bacteria colonization and enhancing bone-building mechanisms.
- Enhanced visibility on imaging: Unlike metal implants, silicon nitride allows for clear visualization of the surrounding tissues in X-rays and CT scans.
“FDA clearance of our SINAPTIC portfolio is a defining commercial milestone for the Company,” said Eric Olson, Chairman, President & CEO. “By entering the high-value, procedure-driven market with a differentiated biomaterial and surgeon-validated designs, we expect to generate meaningful clinical impact and build shareholder value as we execute our commercial strategy.”
Industry estimates place the global foot & ankle device market at approximately
For more information on SINTX Technologies or its materials platform, visit www.sintx.com.
About SINTX Technologies, Inc.
Located in Salt Lake City, Utah, SINTX Technologies is an advanced ceramics company that develops and commercializes materials, components, and technologies for medical and other high-value applications. SINTX is a global leader in the research, development, and manufacturing of silicon nitride, and its products have been implanted in humans since 2008. Through innovation and strategic partnerships, SINTX continues to expand its portfolio across multiple markets.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the Company’s plans and expected timing for commercialization of the SINAPTIC™ Foot & Ankle Osteotomy Wedge System; anticipated surgeon adoption, procedural and operating-room efficiencies, and revenue impact; planned product configurations such as sterile, single-use instrumentation; expected U.S. based manufacturing scale-up, supply-chain efficiency, and quality systems; the Company’s commercialization strategy, ability to generate clinical impact and build shareholder value; and market size and growth expectations, trends, and the associated commercial opportunity. Forward-looking statements are based on current expectations and are often identified by words such as “may,” “will,” “could,” “should,” “would,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “project,” “target,” “continue,” and similar expressions. These statements involve risks and uncertainties that could cause actual results to differ materially, including risks related to commercialization execution, surgeon training and utilization, inventory and channel build-out, manufacturing scale-up and quality, supply chain and third-party components, pricing and reimbursement, hospital and ASC purchasing dynamics, competitive products, intellectual property, integration of acquisitions, macroeconomic conditions, and the accuracy of third-party market estimates. FDA 510(k) clearance does not assure commercial success, and any discussion of potential infection-prevention attributes of silicon nitride reflects platform-level materials research and is not part of the cleared indications for this system. Additional risks and uncertainties are described in SINTX’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, available at www.sec.gov. Forward-looking statements speak only as of the date of this release, and SINTX undertakes no obligation to update them, except as required by law.
SINTX Contacts:
Jack Perkins or Maria Hocut
KCSA Strategic Communications
Sintx@kcsa.com
SINTX Technologies, Inc.
801.839.3502
IR@sintx.com
FAQ
What did SINTX announce about the SINAPTIC system on October 20, 2025 (SINT)?
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How does SINTX say silicon nitride benefits foot and ankle implants (SINT)?
What market opportunity did SINTX reference for foot & ankle devices (SINT)?
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