Sintx Technologies (SINT) FDA Approvals

Sintx Technologies' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Sintx Technologies (SINT). Over the past two years, Sintx Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SINAPTIC. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

SINAPTIC FDA Regulatory Events

SINAPTIC is a drug developed by Sintx Technologies for the following indication: Foot & Ankle Osteotomy Wedge System. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - March 19,2026

• Drug: SINAPTIC
• Announced Date: March 19, 2026
• Indication: Foot & Ankle Osteotomy Wedge System

SINTX Technologies, Inc. announced the successful completion of the first-in-human surgical procedure utilizing its FDA-cleared SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a major clinical and commercial milestone in the Company's expansion into the global orthopedic device market.

SINTX Technologies announced the successful completion of the first-in-human surgical use of its FDA-cleared SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a major clinical and commercial milestone as the company expands into the global foot and ankle reconstruction market. The procedure was performed March 13, 2026 by Dr. Scott Carrington, DPM, FACFAS, at Emplify Health in La Crosse, Wisconsin. Surgeons reported the implant provided the needed structural integrity and clear imaging crucial for reconstructive cases.

The SINAPTIC wedge uses SINTX’s silicon nitride biomaterial, noted for osteoconductive and pro-osteogenic properties, a bacteriostatic surface, hydrophilicity, and compatibility with X-ray, CT, and MRI. These features may help bone integration, reduce bacterial adhesion, and improve post-operative imaging, potentially aiding clinical decision-making and patient recovery.

SINTX views this case as an important step toward commercial adoption of the SINAPTIC platform, broader orthopedic applications beyond spine, and a planned U.S. commercial launch to support long-term growth.

Provided Update - October 20,2025

• Drug: SINAPTIC
• Announced Date: October 20, 2025
• Indication: Foot & Ankle Osteotomy Wedge System

SINTX Technologies, Inc. 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.

SINTX Technologies announced U.S. Food and Drug Administration 510(k) clearance for its SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking the company’s entry into reconstructive foot and ankle surgery in the United States. The implant combines SINTX’s proprietary silicon nitride biomaterial with surgeon-informed designs and a sterile, single-use instrument kit engineered to enhance surgical efficiency, precision and reproducibility. By blending advanced material science with practical innovation, SINAPTIC aims to address unmet clinical needs in foot and ankle procedures and support long-term company growth.

SINTX plans a U.S. commercial launch in Q1 2026, leveraging its U.S.-based manufacturing to accelerate revenue and improve operating efficiency. The non-metal, pro-osteogenic and bacteriostatic properties of silicon nitride also offer better bone integration and clear imaging on X-rays and CT scans. Targeting a multibillion-dollar market, SINTX expects the new system to drive meaningful clinical impact and create shareholder value as part of its broader biomaterials platform strategy.