Breakthrough Device for Pelvic Fracture Fixation Used in First Patient Implant

SI-BONE Inc. has marked the first-in-patient procedures with its U.S. Food and Drug Administration (FDA)-designated breakthrough device, the iFuse TORQ TNT Implant System (TNT).

“We are thrilled with the successful completion of these initial procedures using our iFuse TORQ TNT system,” SI-Bone CEO Laura Francis said. “This breakthrough technology marks a significant step forward in addressing the unmet clinical needs of complex pelvic fragility fractures. By providing a solution that improves both surgical efficiency and patient recovery, we are further expanding our leadership in the sacropelvic space.”

TNT is designed to address the anatomic and biomechanical challenges of pelvic fragility fractures, particularly in patients with poor bone quality. SI-Bone claims the product offers a significant advancement over traditional cannulated screws.
 
Gaining FDA 510(k) clearance and Breakthrough Device Designation in August, TNT is the first 3D-printed transiliac-transsacral screw cleared for the U.S. market. It features a pelvis-specific design to improve initial fixation and reduce the risk of screw backout. Among the first surgeons to perform procedures with TNT were Edward Westrick, M.D., at Allegheny General Hospital in Pittsburgh, Pa.; Reza Firoozabadi, M.D., at Harborview Medical Center in Seattle; J.D. Black, M.D., at Kadlec Regional Medical Center in Richland, Wash.; and Brian Cunningham, M.D., vice chair and director of Orthopedics at Methodist Hospital – HealthPartners in St. Louis Park, Minn.
 
“TNT went beyond my expectations,” Dr. Black stated. “The streamlined instrumentation and implant design not only provided excellent fixation but also allowed for quick, precise implantation. This efficiency is critical when treating patients with fragile bones, as it reduces operating time, minimizes risks, and leads to faster recovery.”
 
“TNT’s 3D-printed porous surface facilitates osseointegration, which I believe will lead to better long-term outcomes for my older, osteoporotic patients,” Dr. Cunningham concluded.
 
SI-BONE develops surgical treatments for sacropelvic disorders. Since pioneering minimally invasive surgery of the SI joint in 2009, SI-BONE has supported over 3,900 surgeons in performing more than 100,000 sacropelvic procedures. A body of clinical evidence supports the use of SI-BONE’s technologies, including two randomized controlled trials and more than 135 peer-reviewed publications. SI-BONE has leveraged its leadership in minimally invasive SI joint fusion to commercialize novel solutions for adjacent markets, including adult deformity, spinopelvic fixation, and pelvic trauma.
 
* Drs. Edward Westrick, Reza Firoozabadi, and J.D. Black are paid consultants for SI-BONE Inc.