SI-BONE Receives FDA Nod for Its TNT Implant System
SI-BONE, Inc. (NASDAQ: SIBN) has recently received FDA 510(k) clearance for its iFuse TORQ TNT implant system (“TNT”). The TNT implant system is the first anatomy-specific system designed to meet the biomechanical challenges presented by pelvic fragility fractures.
FDA has determined that TNT has the potential to provide more effective treatment of pelvic fragility fractures than the current standard of care, such as cannulated screws. The latest development highlights SI-BONE’s capability to develop a platform of unique solutions that target large unmet clinical needs.
About the TNT Implant System
The TNT implant system is designed for the specific anatomical and bone mineral density needs of the sacrum and ilium. TNT comes with a porous threaded implant with lengths capable of spanning the posterior pelvis, passing through the ipsilateral ilium, sacrum and into the contralateral ilium. It includes a system specially designed for sacropelvic anatomy to reduce the rate of screw backout.
TNT improves early fixation and reduces the rate of screw backout, which may allow for early patient weight-bearing and mobilization. It will serve as the next-generation technology for pelvic fragility fracture fixation …
Full story available on Benzinga.com