FDA Events for SiBone (SIBN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by SiBone (SIBN).
Over the past two years, SiBone has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
iFuse. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
iFuse TORQ TNT™ Implant System (TNT) - FDA Regulatory Timeline and Events
iFuse TORQ TNT™ Implant System (TNT) is a drug developed by SiBone for the following indication: For Pelvic Fracture Fixation 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:
- iFuse TORQ TNT™ Implant System (TNT)
- Announced Date:
- October 10, 2024
- Indication:
- For Pelvic Fracture Fixation System
Announcement
SI-BONE, Inc. announced first-in-patient procedures with the FDA-designated breakthrough device, iFuse TORQ TNT™ Implant System (TNT).
AI Summary
SI-BONE, Inc. recently announced the first-in-patient procedures using its new FDA-designated breakthrough device, the iFuse TORQ TNT™ Implant System. This innovative system is the first 3D-printed transiliac-transsacral screw cleared for market use in the U.S., designed to treat pelvic fragility fractures in patients with poor bone quality. The TNT device offers improved fixation, reduced risk of screw backout, and a porous surface that promotes osseointegration. Surgeons noted that its streamlined instrumentation and precise implant design not only enhanced fixation but also reduced operating time, which is crucial for patients with delicate bones. This breakthrough technology marks an important advancement in addressing complex pelvic trauma while potentially improving long-term outcomes for patients. SI-BONE’s announcement reinforces its commitment to developing advanced surgical solutions for sacropelvic disorders.
Read Announcement- Drug:
- iFuse TORQ TNT™ Implant System (TNT)
- Announced Date:
- August 20, 2024
- Indication:
- For Pelvic Fracture Fixation System
Announcement
SI-BONE, Inc., announces FDA 510(k) clearance of the iFuse TORQ TNT™ Implant System (TNT). The TNT implant system is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium and will serve as the next generation technology for pelvic fragility fracture fixation and sacroiliac joint fusion.
AI Summary
SI‑BONE, Inc. has received FDA 510(k) clearance for its new iFuse TORQ TNT™ Implant System (TNT). This implant system is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium. It is the next generation in technology for fixing pelvic fragility fractures and for sacroiliac joint fusion, offering a promising alternative to older methods.
The TNT system features a porous threaded implant that spans the posterior pelvis, passing from the ipsilateral ilium, through the sacrum, and into the contralateral ilium. Approved as a Breakthrough Device by the FDA, it aims to improve early fixation and reduce the rate of screw backout. This design may help frail and elderly patients return to mobility more quickly by allowing earlier weight-bearing and movement after surgery.
Read Announcement
SiBone FDA Events - Frequently Asked Questions
As of now, SiBone (SIBN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, SiBone (SIBN) has reported FDA regulatory activity for iFuse TORQ TNT™ Implant System (TNT).
The most recent FDA-related event for SiBone occurred on October 10, 2024, involving iFuse TORQ TNT™ Implant System (TNT). The update was categorized as "Designation Grant," with the company reporting: "SI-BONE, Inc. announced first-in-patient procedures with the FDA-designated breakthrough device, iFuse TORQ TNT™ Implant System (TNT)."
Currently, SiBone has one therapy (iFuse TORQ TNT™ Implant System (TNT)) targeting the following condition: For Pelvic Fracture Fixation 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:SIBN) was last updated on 7/11/2025 by MarketBeat.com Staff
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