SINTX Technologies Inc. has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its silicon nitride osteotomy wedges—a move that mark the company’s official entry into the foot and ankle reconstruction market. The next-generation implants blend cutting-edge biomaterials science with surgical precision and are designed to elevate standards in orthopedic procedures, according to SINTX.

The FDA submission is backed by more than a decade of clinical and preclinical data on SINTX’s Si₃N₄ biomaterial, including peer-reviewed publications, biocompatibility studies, and documented fusion success.

The devices are manufactured from SINTX’s proprietary medical-grade silicon nitride, a biomaterial with a proven clinical track record of more than 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 $750.5 million; industry data show the sector’s value growing to $1.38 billion by 2032.

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,” SINTX Technologies CEO Eric Olson said.

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, each implant system is expected 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,” SINTX Technologies Chief Commercial Officer Lisa Marie Del Re stated. “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.”

With clinical advantages and meaningful input from high-volume reconstructive surgeons, the company anticipates strong early adoption of its foot and ankle portfolio. The design and material properties of SINTX Technologies’ silicon nitride implants are intended to support successful bone fusion and to reduce infection risk; key considerations in recovery and long-term outcomes.

Engineered for enhanced intraoperative visualization and ease of use, the system integrates advanced implant geometry with streamlined instrumentation to support surgical precision and procedural consistency. 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,” Olson said. “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. SINTX Technologies acquired SiNAPTIC on July 1.

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 researches, develops, and manufactures silicon nitride, and its products have been implanted in humans since 2008. Over the past several years, SINTX has used strategic acquisitions and alliances to enter new markets.