SINTX Technologies Completes First Human Surgery with FDA-Cleared SINAPTIC Foot & Ankle Implant
SINTX’s SINAPTIC Foot & Ankle Osteotomy Wedge System, FDA 510(k)-cleared in October 2025, was first implanted in a human on March 13, 2026, marking the company’s entry into the foot and ankle reconstruction market. Its silicon nitride implant’s osteoconductive, bacteriostatic and imaging-compatible properties support SINTX’s commercialization and revenue growth.
1. First-In-Human Surgery
On March 13, 2026, Dr. Scott Carrington at Emplify Health in La Crosse, Wisconsin completed the first procedure using the SINAPTIC Foot & Ankle Osteotomy Wedge System. This milestone transitions SINTX from preclinical research to real-world surgical applications in reconstructive foot and ankle procedures.
2. SINAPTIC System Features and Clearance
The SINAPTIC Foot & Ankle Osteotomy Wedge received FDA 510(k) clearance in October 2025 and integrates surgeon-informed design with silicon nitride’s osteoconductive, pro-osteogenic and bacteriostatic surface properties. Its compatibility with X-ray, CT and MRI imaging enhances intraoperative guidance and postoperative assessment.
3. Commercialization and Market Entry
Entry into the foot and ankle reconstruction segment broadens SINTX’s addressable opportunity within the multi-billion-dollar orthopedic implant industry. The company is preparing for a U.S. commercial launch to drive revenue growth and expand surgeon adoption of its silicon nitride biomaterial platform.