SI-BONE has received FDA 510(k) clearance breakthrough device iFuse TORQ TNT™ Implant System (TNT) for Pelvic Fracture Fixation System.
This innovative implant system is modified to accommodate the unique anatomical features and bone mineral density requirements of the sacrum and ilium.
It represents the next generation of technology for fixing pelvic fragility fractures and performing sacroiliac joint fusions.
TNT features a porous threaded implant designed to extend across the posterior pelvis, traversing the ipsilateral ilium and sacrum before reaching the contralateral ilium (referred to as “through and through” or “TNT”).
It has the probability to provide more effective treatment of pelvic fragility fractures than the current standard of care, cannulated screws. TNT is designed to enhance initial fixation and minimize the likelihood of screw backout, potentially enabling earlier weight-bearing and mobilization for patients.
iFuse TORQ TNT™ Implant System is designed specifically for the sacropelvic anatomy that may reduce the rate of screw backout in patient population. The implant is accompanied by instrumentation to match modern surgical techniques.
This device receive the designation which highlights the ability to develop a platform of unique solutions that target large unmet clinical needs.
Source: https://www.globenewswire.com/news-release/2024/08/20/2932785/0/en/SI-BONE-Inc-Receives-510-k-Clearance-and-FDA-Breakthrough-Device-Designation-for-Pelvic-Fracture-Fixation-System.html
