SI-BONE received FDA 510(k) clearance to market the iFuse TORQ TNT Implant System (TNT). TNT 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 was also awarded Breakthrough Device Designation by FDA.
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 (through and through, thus “TNT”). TNT is designed to improve early fixation and reduce the rate of screw backout, which may allow for early patient weight-bearing and mobilization.
“We are pleased the FDA recognized TNT as a Breakthrough Device. The number of people bedbound from pain related to pelvic fragility fractures is large and growing,” said Laura Francis, CEO of SI-BONE. “As the leader in the sacropelvic space we’re honored to be able to help surgeons get their frail and elderly patients back to mobility sooner, by providing the first anatomy-specific system designed to meet the biomechanical challenges presented by pelvic fragility fractures. After iFuse Bedrock Granite, which also was a Breakthrough Device, this is our second device to receive the designation. This highlights our ability to develop a platform of unique solutions that target large unmet clinical needs.”
SI-BONE received FDA 510(k) clearance to market the iFuse TORQ TNT Implant System (TNT). TNT 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 was also awarded Breakthrough...
SI-BONE received FDA 510(k) clearance to market the iFuse TORQ TNT Implant System (TNT). TNT 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 was also awarded Breakthrough Device Designation by FDA.
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 (through and through, thus “TNT”). TNT is designed to improve early fixation and reduce the rate of screw backout, which may allow for early patient weight-bearing and mobilization.
“We are pleased the FDA recognized TNT as a Breakthrough Device. The number of people bedbound from pain related to pelvic fragility fractures is large and growing,” said Laura Francis, CEO of SI-BONE. “As the leader in the sacropelvic space we’re honored to be able to help surgeons get their frail and elderly patients back to mobility sooner, by providing the first anatomy-specific system designed to meet the biomechanical challenges presented by pelvic fragility fractures. After iFuse Bedrock Granite, which also was a Breakthrough Device, this is our second device to receive the designation. This highlights our ability to develop a platform of unique solutions that target large unmet clinical needs.”
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