Aurora Spine has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its patented minimally invasive SiLO TFX MIS sacroiliac joint fixation system.
The Aurora Spine SiLO TFX MIS sacroiliac joint fixation system is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The system includes a transfixing-cone, an ilium screw, a sacrum screw and associated instrumentation. The SiLO TFX implants are designed to transfix the sacrum and ilium, providing stability for bony fusion.
Trent Northcutt, Aurora Spine’s president and chief executive officer, said: “We are pleased with our continued commercial momentum as we expand our footprint for providing differentiated surgical devices in the sacropelvic/sacroiliac space.
“We will make meaningful investments in our sales force and physician training, which we believe will enable us to further capitalise on the growth in outpatient surgery centres across the United States.”
Laszlo Garamszegi, the company’s chief technology officer, added: “We are excited about this patented game-changing technology. Increased awareness of SI joint disruption as a significant contributor to back pain led us to develop a minimally invasive solution to treat the condition. It is a breakthrough for Aurora to offer a titanium version of our SiLO family of products, which offers additional fixation options to transfix the joint.”
Michael Stoffman, a neurosurgeon at the University at Buffalo Neurosurgery (Williamsville, USA), commented: “This is a significant milestone in the evolution of the treatment of SI joint dysfunction and clearly sets SiLO TFX apart from any other surgical options. This patented system transfixes the sacrum and ilium to provide superior clinical outcomes. The SiLO TFX clearance is an essential milestone for Aurora Spine as they are committed to helping patients experiencing chronic SI joint pain.”