SI-Bone earned FDA 510(k) clearance and breakthrough device designation for the iFuse Torq TNT implant system, according to an Aug. 21 news release.
The implants are designed for pelvic fragility fracture fixation and sacroiliac joint fusion. TNT has a porous threaded implant with lengths that can span the posterior pelvis, and it earned breakthrough device designation.
Breakthrough device designation indicates the implant system's potential to provide more effective treatment of pelvic fragility fractures compared to cannulated screws.
"The current smooth stainless steel cannulated screws we are using in the pelvis were designed decades ago for fixing hip fractures," Charles Moon, MD, director of orthopedic trauma at Los Angeles-based Cedars-Sinai, said in the release. "When trauma surgeons began modernizing their techniques for pelvic fracture fixation, they simply started using longer screws ... 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.