SINTX Technologies Receives FDA Clearance for SINAPTIC® Foot & Ankle Implant System
Rhea-AI Summary
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).
Positive
- 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
Negative
- 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
News Market Reaction 11 Alerts
On the day this news was published, SINT declined 15.40%, reflecting a significant negative market reaction. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $14M at that time. Trading volume was exceptionally heavy at 53.4x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
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)?
When will SINTX (SINT) launch the SINAPTIC system in the U.S.?
How does SINTX say silicon nitride benefits foot and ankle implants (SINT)?
What market opportunity did SINTX reference for foot & ankle devices (SINT)?
Will SINTX manufacture the SINAPTIC system in the U.S. (SINT)?
Are SINTX's bacteriostatic claims for SINAPTIC supported by human clinical trials (SINT)?
