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.
- Drug:
- SINAPTIC
- Announced Date:
- October 20, 2025
- Indication:
- Foot & Ankle Osteotomy Wedge System
Announcement
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.
AI Summary
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.
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Sintx Technologies FDA Events - Frequently Asked Questions
As of now, Sintx Technologies (SINT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Sintx Technologies (SINT) has reported FDA regulatory activity for SINAPTIC.
The most recent FDA-related event for Sintx Technologies occurred on October 20, 2025, involving SINAPTIC. The update was categorized as "Provided Update," with the company reporting: "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."
Currently, Sintx Technologies has one therapy (SINAPTIC) targeting the following condition: Foot & Ankle Osteotomy Wedge System.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:SINT) was last updated on 10/20/2025 by MarketBeat.com Staff
