SI-Bone receives 510(k) clearance, BDD for iFuse TORQ TNT Implant System

SI-BONE announces FDA 510(k) clearance of the iFuse TORQ TNT Implant System. 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. TNT includes a porous threaded implant with lengths capable of spanning the posterior pelvis, passing through the ipsilateral ilium, sacrum, and into the contralateral ilium. TNT was awarded Breakthrough Device Designation by the FDA. In designating TNT as a Breakthrough Device, the FDA determined that it has the potential to provide more effective treatment of pelvic fragility fractures than the current standard of care, cannulated screws. TNT is designed to improve early fixation and reduce the rate of screw backout, which may allow for early patient weight-bearing and mobilization.