Si-Bone this week announced it received FDA 510(k) clearance and FDA breakthrough device designation for its iFuse Torq TNT Implant System.
The Santa Clara, California-based orthopedic company designed the TNT implant for pelvic fragility fracture fixation and sacroilliac joint fusion. TNT (through and through) is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium.
“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,” CEO Laura Francis said in a news release. “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.”
TNT is a porous threaded implant with lengths that can span the posterior pelvis and pass through the ipsilateral ilium, sacrum and into the contralateral ilium. It received breakthrough designation from the FDA, which, according to Si-Bone, means the federal agency determined it has the potential to provide more effective treatment of pelvic fragility fractures with cannulated screws, which is the standard of care.
“The current smooth stainless steel cannulated screws we are using in the pelvis were designed decades ago for fixing hip fractures. When trauma surgeons began modernizing their techniques for pelvic fracture fixation, they simply started using longer screws. Numerous clinical studies have shown significant issues with this strategy, especially in the geriatric population. Screw loosening can cause pain, which can slow a patient’s progress postoperatively and may require a second surgery. As surgeons we really want to avoid second surgeries in the elderly,” Dr. Charles Moon, the director of orthopedic trauma at Cedars-Sinai, said in a news release.
Si-Bone’s implant can improve early fixation and reduce the rate of screw backout to allow for early patient weight-bearing and mobilization.
“With TNT, there is now a system designed specifically for the sacropelvic anatomy that may reduce the rate of screw backout in this patient population. The implant is accompanied by instrumentation to match modern surgical techniques. I am very excited for the many patients who will benefit from this new technology,” Moon said.
