SINTX Technologies Submits FDA 510(k) for Silicon Nitride Foot & Ankle Medical Devices
SINTX Technologies (NASDAQ: SINT) has submitted a 510(k) premarket notification to the FDA for its innovative silicon nitride osteotomy wedges, marking its entry into the $750.5 million foot and ankle fusion market. The company's proprietary silicon nitride (Si₃N₄) technology has already been used in over 50,000 spinal interbody fusion devices since 2008.
The new implants offer key advantages including pro-osteogenic properties, antimicrobial capabilities without additives, and superior radiographic clarity. SINTX's solution combines advanced biomaterial science with disposable instrumentation, targeting a market expected to reach $1.38 billion by 2032.
This strategic launch follows SINTX's recent acquisition of SiNAPTIC Surgical on July 1, 2025, positioning the company for significant revenue growth in both hospital and ambulatory surgery center settings.
SINTX Technologies (NASDAQ: SINT) ha presentato una notifica premarket 510(k) alla FDA per i suoi innovativi cunei osteotomici in nitruro di silicio, segnando il suo ingresso nel mercato della fusione di piede e caviglia da 750,5 milioni di dollari. La tecnologia proprietaria dell'azienda basata sul nitruro di silicio (Si₃N₄) è già stata utilizzata in oltre 50.000 dispositivi per la fusione intersomatica spinale dal 2008.
I nuovi impianti offrono vantaggi chiave come proprietà pro-osteogeniche, capacità antimicrobiche senza l’uso di additivi e una superiore chiarezza radiografica. La soluzione di SINTX combina scienza avanzata dei biomateriali con strumenti monouso, puntando a un mercato che si prevede raggiungerà 1,38 miliardi di dollari entro il 2032.
Questo lancio strategico segue l'acquisizione recente da parte di SINTX di SiNAPTIC Surgical il 1° luglio 2025, posizionando l'azienda per una crescita significativa dei ricavi sia negli ospedali che nei centri di chirurgia ambulatoriale.
SINTX Technologies (NASDAQ: SINT) ha presentado una notificación premarket 510(k) a la FDA para sus innovadoras cuñas de osteotomía de nitruro de silicio, marcando su entrada en el mercado de fusión de pie y tobillo de 750,5 millones de dólares. La tecnología patentada de nitruro de silicio (Si₃N₄) de la compañía ya se ha utilizado en más de 50,000 dispositivos de fusión intersomática espinal desde 2008.
Los nuevos implantes ofrecen ventajas clave, incluyendo propiedades pro-osteogénicas, capacidades antimicrobianas sin aditivos y una claridad radiográfica superior. La solución de SINTX combina ciencia avanzada de biomateriales con instrumentación desechable, apuntando a un mercado que se espera alcance los 1.38 mil millones de dólares para 2032.
Este lanzamiento estratégico sigue a la reciente adquisición de SiNAPTIC Surgical por parte de SINTX el 1 de julio de 2025, posicionando a la empresa para un crecimiento significativo de ingresos tanto en hospitales como en centros de cirugía ambulatoria.
SINTX Technologies (NASDAQ: SINT)는 혁신적인 실리콘 나이트라이드 절골 쐐기에 대해 FDA에 510(k) 사전시장 통지를 제출하며 7억 5,050만 달러 규모의 족부 및 발목 융합 시장에 진출했습니다. 회사의 독자적인 실리콘 나이트라이드(Si₃N₄) 기술은 2008년 이후 50,000개 이상의 척추 간 융합 장치에 이미 사용되었습니다.
새로운 임플란트는 첨단 골형성 촉진 특성, 첨가물 없는 항균 기능, 뛰어난 방사선 투과도를 포함한 주요 이점을 제공합니다. SINTX의 솔루션은 첨단 생체재료 과학과 일회용 기구를 결합하여 2032년까지 13억 8천만 달러에 이를 것으로 예상되는 시장을 겨냥하고 있습니다.
이번 전략적 출시는 2025년 7월 1일 SINTX가 SiNAPTIC Surgical을 최근 인수한 데 이어 이루어졌으며, 병원 및 외래 수술 센터 환경 모두에서 상당한 매출 성장을 기대하게 합니다.
SINTX Technologies (NASDAQ : SINT) a soumis une notification précommerciale 510(k) à la FDA pour ses coins d’ostéotomie en nitrure de silicium innovants, marquant son entrée sur le marché de la fusion du pied et de la cheville de 750,5 millions de dollars. La technologie propriétaire de nitrure de silicium (Si₃N₄) de la société a déjà été utilisée dans plus de 50 000 dispositifs de fusion intersomatique vertébrale depuis 2008.
Les nouveaux implants offrent des avantages clés, notamment des propriétés pro-ostéogéniques, des capacités antimicrobiennes sans additifs et une clarté radiographique supérieure. La solution de SINTX combine une science avancée des biomatériaux avec des instruments jetables, ciblant un marché qui devrait atteindre 1,38 milliard de dollars d’ici 2032.
Ce lancement stratégique fait suite à l’acquisition récente de SiNAPTIC Surgical par SINTX le 1er juillet 2025, positionnant l’entreprise pour une croissance significative de ses revenus tant dans les hôpitaux que dans les centres de chirurgie ambulatoire.
SINTX Technologies (NASDAQ: SINT) hat eine 510(k) Premarket-Benachrichtigung bei der FDA für seine innovativen Siliziumnitrid-Osteotomiekeile eingereicht und damit den Eintritt in den 750,5 Millionen US-Dollar schweren Markt für Fuß- und Sprunggelenksfusionen markiert. Die firmeneigene Siliziumnitrid (Si₃N₄)-Technologie wurde seit 2008 bereits in über 50.000 spinalen Interbody-Fusionsgeräten eingesetzt.
Die neuen Implantate bieten wichtige Vorteile wie pro-osteogene Eigenschaften, antimikrobielle Fähigkeiten ohne Zusatzstoffe und überlegene radiologische Klarheit. Die Lösung von SINTX verbindet fortschrittliche Biomaterialwissenschaften mit Einweg-Instrumenten und zielt auf einen Markt ab, der bis 2032 voraussichtlich 1,38 Milliarden US-Dollar erreichen wird.
Dieser strategische Markteintritt folgt auf die kürzliche Übernahme von SiNAPTIC Surgical durch SINTX am 1. Juli 2025 und positioniert das Unternehmen für erhebliches Umsatzwachstum sowohl in Krankenhäusern als auch ambulanten Operationszentren.
- Proven track record with over 50,000 spinal devices implanted since 2008
- Targeting large market opportunity valued at $750.5M with projected growth to $1.38B by 2032
- Superior product features including antimicrobial properties and enhanced bone fusion capabilities
- Strategic acquisition of SiNAPTIC Surgical strengthens market position
- Cost-effective solution with disposable instrumentation reducing operational costs
- Pending FDA approval creates regulatory uncertainty
- New market entry requires establishing market presence and adoption
- Competition from established foot and ankle medical device manufacturers
Insights
SINTX's FDA submission for silicon nitride foot/ankle implants targets a $750M+ market with clinically differentiated technology.
SINTX Technologies has submitted a 510(k) application to the FDA for silicon nitride osteotomy wedges, representing a strategic expansion beyond their established spinal implant business. This submission marks their entry into the foot and ankle reconstruction market, currently valued at
The technology leverages SINTX's proprietary silicon nitride (Si₃N₄) biomaterial, which has already been used in over 50,000 spinal implants since 2008. What makes this submission particularly noteworthy is the material's differentiated clinical profile compared to competitive materials like PEEK and titanium. Silicon nitride offers three key advantages: pro-osteogenic properties that actively promote bone growth, inherent antimicrobial characteristics without requiring additional coatings or treatments, and radiographic clarity that allows for precise placement and post-operative assessment.
The company's approach combines material science innovation with surgical workflow improvements through proprietary implant geometries and disposable instrumentation. This dual focus addresses both clinical outcomes and operational efficiency, potentially positioning SINTX favorably with hospital administrators and surgeons alike.
This submission represents a critical milestone in SINTX's commercialization strategy. While FDA clearance timing remains uncertain, the existing clinical history with silicon nitride in spinal applications may facilitate the regulatory review process. The company recently acquired SiNAPTIC Surgical (July 1, 2025), which will serve as the distribution channel for these products, suggesting SINTX is building out commercial infrastructure in anticipation of market entry.
For a small medical device company, successfully entering the foot and ankle market could significantly diversify revenue streams and reduce reliance on their existing product portfolio. The foot and ankle segment has seen increased investor interest due to its growth trajectory and relative resilience to reimbursement pressures compared to other orthopedic sectors.
Advanced Material Science Meets Surgical Precision in Groundbreaking New Platform in Reconstructive Foot & Ankle Surgery Market
SALT LAKE CITY, Utah, July 22, 2025 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”), an advanced ceramics innovator specializing in silicon nitride (Si₃N₄) for medical applications, today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its novel silicon nitride osteotomy wedges—marking the official entry into the foot and ankle reconstruction market. These next-generation implants blend cutting-edge biomaterials science with surgical precision and are designed to elevate standards in orthopedic procedures.
The devices are manufactured from SINTX’s proprietary medical-grade silicon nitride, a biomaterial with a proven clinical track record of over 50,000 spinal interbody fusion devices implanted since 2008. With this submission, SINTX is extending the success of Si₃N₄ beyond the spine and into the global foot and ankle fusion market, currently valued at approximately
Clinical Advantages of Silicon Nitride
From a clinical standpoint, Si₃N₄ is uniquely positioned among biomaterials to solve several of the most pressing challenges in orthopedic reconstruction:
- Pro-osteogenic: Unlike PEEK or titanium, Si₃N₄ has been shown to actively promote bone cell adhesion, proliferation, and differentiation. In vivo and in vitro studies have shown enhanced osseointegration and fusion potential due to the material’s inherent surface chemistry and nanotopography.
- Antimicrobial Without Additives: Si₃N₄ has been shown to inhibit bacterial colonization and proliferation—including several antibiotic-resistant strains —through inherent surface chemistry without a supplemental coating. This is particularly critical in foot and ankle procedures where occurrences of hardware-related infections persist despite current best practices.
- Radiographic Clarity: Si₃N₄ implants are intrinsically radiolucent with clearly visible boundaries on X-ray and CT scans. This facilitates precise intraoperative placement and clear post-operative evaluation of bone healing—unlike metal implants which obscure fusion assessment.
“We believe Si₃N₄ is the ideal orthopedic biomaterial for fusion procedures where infection risk, healing rate, and long-term stability are paramount,” said Eric Olson, CEO of SINTX Technologies.
Surgical Innovation: Proprietary Designs with Disposable Instrumentation
In parallel with biomaterial excellence, SINTX has engineered proprietary implant geometries and disposable instrumentation to elevate surgical outcomes:
- Implant Geometry: The family of wedges were developed in collaboration with leading foot and ankle surgeons to optimize for biomechanical correction, surface area contact, and ease of insertion.
- Disposable Instrument Set: At full launch we anticipate each implant system to be paired with a sterile, single-use instrument kit to enhance maximum surgical efficiency and sterility. This potentially leads to a reduction in intraoperative delays, elimination of reprocessing errors, and a decrease in OR turnover time—benefits that hospitals and ambulatory surgery centers alike will value.
“We’ve combined the novel clinical advantages of silicon nitride with intuitive implant designs and single-use instrumentation to deliver a truly differentiated solution,” said Lisa Marie Del Re, Chief Commercial Officer of SINTX Technologies. “This approach goes beyond innovation in material science. We’ve reimagined the surgical experience, striving to improve outcomes, enhance efficiency, and deliver stronger economic value across the care continuum.”
Strategic Launch and Financial Outlook
- The FDA submission is backed by over a decade of clinical and preclinical data on SINTX’s Si₃N₄ biomaterial, including peer-reviewed publications, biocompatibility studies, and documented fusion success.
- With compelling clinical advantages and meaningful input from high-volume reconstructive surgeons, the company anticipates strong early adoption of its foot and ankle portfolio. This launch represents a key growth catalyst for SINTX, with the potential to drive meaningful revenue through broader market penetration and increasing procedural demand across both hospital and ambulatory surgery center settings.
Delivering Value to All Stakeholders
- For Patients: The design and material properties of our silicon nitride implants are intended to support successful bone fusion and to reduce infection risk; key considerations in recovery and long-term outcomes.
- For Surgeons: Engineered for enhanced intraoperative visualization and ease of use, our system integrates advanced implant geometry with streamlined instrumentation to support surgical precision and procedural consistency.
- For Providers and Stakeholders: The combination of sterile, single-use kits and differentiated biomaterial technology offers operational efficiencies and clinical distinction, positioning this platform for strong alignment with evolving value-based care models and increased procedural demand.
“This is not just another foot fusion product line—this is a platform,” added Olson. “A platform built on a proven material, rooted in over a decade of clinical experience, and refined with thoughtful surgical design. We believe SINTX is redefining what’s possible in orthopedic advancements.”
The implants will be manufactured at SINTX Technologies FDA audited and ISO certified manufacturing facility and distributed under the company name SiNAPTIC Surgical. SiNAPTIC was acquired by SINTX on July 1, 2025.
For more information, visit www.sintx.com or www.sinaptic.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 agribiotech 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. Over the past several years, SINTX has utilized strategic acquisitions and alliances to enter new markets. For more information on SINTX Technologies or its materials platform, visit www.sintx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties. Forward-looking statements can be identified by words such as: "anticipate," "believe," "project," "estimate," "expect," "strategy,” "future," "likely," "may," "should," "will" and similar references to future periods.
Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Forward-looking statements in this press release include our anticipation that there will be strong early adoption of our foot and ankle portfolio, that the product launch will represent a key growth catalyst for SINTX, with the potential to drive meaningful revenue through broader market penetration and increasing procedural demand across both hospital and ambulatory surgery center settings. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, difficulty in commercializing ceramic technologies and development of new product opportunities. A discussion of other risks and uncertainties that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements can be found in SINTX’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the SEC on March 19, 2025, and in SINTX’s other filings with the SEC. SINTX undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report, except as required by law.
Business and Media Inquiries for SINTX:
SINTX Technologies, Inc.
801.839.3502
IR@sintx.com
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