SI-BONE Wins FDA Nod for Pelvic Fracture Fixation System

SI-BONE has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its iFuse Torq TNT implant system (TNT).
 
TNT features a porous, threaded implant with lengths able to span the posterior pelvis, passing through the ipsilateral ilium, sacrum, and into the contralateral ilium—through and through, “TNT.”
 
It was granted FDA breakthrough status, as well. This means the FDA decided it has the potential to offer more effective pelvic fragility fracture treatment than the current standard of care, cannulated screws. SI-BONE backed this by stating TNT can improve early fixation and reduce the chance of screw backout, which can allow early patient weight-bearing and mobilization.
 
The TNT implant system meets the anatomical and bone mineral density needs of the sacrum and ilium, according to the company. SI-BONE believes the TNT implant will be the next-gen technology for pelvic fragility fracture fixation and sacroiliac (SI) joint fusion.

 

---

READ MORE: SI-BONE Launches iFuse Bedrock Granite 9.5mm Implant; Completes 1st Surgeries

Current smooth, stainless steel, cannulated screws used in the pelvis were designed decades ago to fix hip fractures, explained Charles Moon, MD, director of orthopedic trauma at Cedars-Sinai. When trauma surgeons modernized pelvic fracture fixation techniques, they simply began using longer screws, Dr. Moon said.
 
“Numerous clinical studies have shown significant issues with this strategy, especially in the geriatric population,” Dr. Moon told the press. “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. 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.”
 
“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,” added 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.”