FDA Events for Paragon 28 (FNA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Paragon 28 (FNA).
Over the past two years, Paragon 28 has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
R3FLEX™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
R3FLEX™ - FDA Regulatory Timeline and Events
R3FLEX™ is a drug developed by Paragon 28 for the following indication: Stabilization System to Anatomically Repair Ankle Syndesmotic Injuries.
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:
- R3FLEX™
- Announced Date:
- September 4, 2024
- Indication:
- Stabilization System to Anatomically Repair Ankle Syndesmotic Injuries
Announcement
Paragon 28, Inc announce the launch of the R3FLEX™ Stabilization System, which is designed to restore stability to the ankle syndesmosis after injury from an ankle fracture or high ankle sprain.
AI Summary
Paragon 28, Inc. has introduced its new R3FLEX™ Stabilization System, specifically designed to restore stability to the ankle syndesmosis after injuries like ankle fractures and high ankle sprains. This innovative device offers surgeons the ability to adjust and visualize tension precisely during surgery with a simple turn of the handle. By doing so, the R3FLEX™ system helps restore the soft tissue to a natural anatomy, which may reduce the risk of developing arthritis and minimize the need for hardware removal.
The system is unique because its tibial implant is positioned on the internal surface of the tibia, potentially lowering the risk of nerve or vein injury compared to other methods that mount hardware externally. Delivered in a single sterile kit, this system simplifies the surgical process and enhances overall patient care in treating complex ankle injuries.
Read Announcement
Paragon 28 FDA Events - Frequently Asked Questions
As of now, Paragon 28 (FNA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Paragon 28 (FNA) has reported FDA regulatory activity for R3FLEX™.
The most recent FDA-related event for Paragon 28 occurred on September 4, 2024, involving R3FLEX™. The update was categorized as "Provided Update," with the company reporting: "Paragon 28, Inc announce the launch of the R3FLEX™ Stabilization System, which is designed to restore stability to the ankle syndesmosis after injury from an ankle fracture or high ankle sprain."
Currently, Paragon 28 has one therapy (R3FLEX™) targeting the following condition: Stabilization System to Anatomically Repair Ankle Syndesmotic Injuries.
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 (NYSE:FNA) was last updated on 7/13/2025 by MarketBeat.com Staff
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