SI-BONE, Inc. announced on October 10, 2024, the successful completion of first-in-patient procedures using its iFuse TORQ TNT™ Implant System (TNT). This system, designed for pelvic fracture fixation, had received 510(k) clearance from the FDA in August 2024 and was awarded Breakthrough Device Designation.
The TNT system is notable as the first 3D-printed transiliac-transsacral screw cleared for market use in the U.S. Its design specifically addresses the anatomical and biomechanical challenges of pelvic fragility fractures, particularly in patients with poor bone quality, aiming to improve initial fixation and reduce screw backout.
Surgeons involved in the initial procedures, including Dr. Edward Westrick and Dr. Brian Cunningham, highlighted the system's streamlined instrumentation, precise implantation, and potential for enhanced osseointegration due to its 3D-printed porous surface. This advancement is expected to lead to better long-term outcomes for older, osteoporotic patients and expand SI-BONE's leadership in the sacropelvic space.
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