Michael Barbella, Managing Editor10.07.22
Aurora Spine Corporation has received U.S. Food and Drug Administration 510(k) clearance of its patented minimally invasive SiLO TFX MIS Sacroiliac Joint Fixation System.
“We are pleased with our continued commercial momentum as we expand our footprint for providing differentiated surgical devices in the sacropelvic/sacroiliac space,” President/CEO Trent Northcutt said. “We will make meaningful investments in our sales force and physician training, which we believe will enable us to further capitalize on the growth in outpatient surgery centers across the United States.”
Intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, the SiLO TFX MIS Sacroiliac Joint Fixation 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.
"We are excited about this patented 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," Chief Technology Officer Laszlo Garamszegi said. "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.”
"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," said Dr. Michael Stoffman, a neurosurgeon at the University at Buffalo Neurosurgery. "The SiLO TFX clearance is an essential milestone for Aurora Spine as they are committed to helping patients experiencing chronic SI Joint pain."
Aurora Spine develops new spinal implant solultions through minimally invasive, regenerative spinal implant technologies.
“We are pleased with our continued commercial momentum as we expand our footprint for providing differentiated surgical devices in the sacropelvic/sacroiliac space,” President/CEO Trent Northcutt said. “We will make meaningful investments in our sales force and physician training, which we believe will enable us to further capitalize on the growth in outpatient surgery centers across the United States.”
Intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, the SiLO TFX MIS Sacroiliac Joint Fixation 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.
"We are excited about this patented 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," Chief Technology Officer Laszlo Garamszegi said. "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.”
"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," said Dr. Michael Stoffman, a neurosurgeon at the University at Buffalo Neurosurgery. "The SiLO TFX clearance is an essential milestone for Aurora Spine as they are committed to helping patients experiencing chronic SI Joint pain."
Aurora Spine develops new spinal implant solultions through minimally invasive, regenerative spinal implant technologies.