First-in-Human Use of FDA-Cleared SINAPTIC Foot & Ankle Implant Reported

SINTX Technologies announced what it described as the first-in-human surgical use of its U.S. FDA-cleared SINAPTIC Foot & Ankle Osteotomy Wedge System, framing the case as a clinical and commercial milestone within its broader orthopedic strategy. In the company’s release, the procedure is presented as an early real-world application of its ceramic biomaterial platform in foot and ankle reconstruction.

The company stated that the SINAPTIC Foot & Ankle Osteotomy Wedge System received U.S. FDA 510(k) clearance in October 2025 and described the product as a foot/ankle osteotomy wedge implant system intended for reconstructive use. It reported that the first procedure was performed March 13, 2026, by Scott Carrington, DPM, FACFAS, at Emplify Health in La Crosse, Wisconsin, using the wedge in a reconstructive foot and ankle procedure.

Dr. Carrington said the implant “performed exceptionally well” and pointed to “structural integrity and imaging clarity” as notable features during the case, additionally describing silicon nitride as “a compelling material” that combines “mechanical performance with biologic interaction.”

SINTX attributed a set of material and design claims to silicon nitride, listing osteoconductive and pro-osteogenic properties, bacteriostatic surface characteristics, hydrophilicity, and radiographic compatibility with X-ray, CT, and MRI. It also noted that these statements are based on laboratory testing and published research and may not be indicative of clinical performance in all cases. Elsewhere, the company contrasted silicon nitride with “traditional metal and plastic implants” and described it as having been studied for bone integration support, reduced bacterial adhesion, and improved postoperative imaging, linking these asserted attributes to its stated commercialization direction for the SINAPTIC platform.

On commercialization, SINTX described the first procedure as a step in a broader strategy to expand beyond spine and position silicon nitride as a platform technology across orthopedic and medical device markets, including SiNERGY SiN/PEEK composites and antipathogenic biomaterials (described as ongoing research and not implying FDA clearance, approved indications, or clinical efficacy). The release stated that the company expects the SINAPTIC system to support a U.S. commercial launch and contribute to long-term growth, and it described SINTX as developing, manufacturing, and commercializing silicon nitride biomaterials and related devices from U.S.-based operations. It also referenced support from a patent portfolio and strategic industry partnerships, presenting these elements as part of the same market-entry narrative as the first use and material-attribute claims.

Key Takeaways:

• SINTX reported a first-in-human surgical use of its FDA 510(k)-cleared SINAPTIC Foot & Ankle Osteotomy Wedge System, following the company’s stated October 2025 510(k) clearance.
• The company described silicon nitride features including osteoconductive/pro-osteogenic properties, bacteriostatic surface characteristics, hydrophilicity, and compatibility with X-ray, CT, and MRI imaging.
• SINTX tied the milestone to commercialization messaging, citing plans for a U.S. launch, platform expansion (including SiNERGY SiN/PEEK composites), U.S.-based manufacturing, and support from patents and partnerships.