The US Food and Drug Administration (FDA) has given Orthofix Medical 510(k) clearance for the nanotechnology feature of the Firebird SI fusion system, the 3D-printed titanium bone screw with nanotechnology designed to compress and stabilise the sacroiliac (SI) joint during fusion.
Orthofix is due to highlight their Nanovate technology, the nanotechnology feature of the Firebird SI fusion system, during the upcoming North American Spine Society (NASS) 2020 annual meeting (7–10 October, virtual).
SI joint dysfunction and pain may be caused by trauma, lifting or twisting, natural childbirth, degeneration from previous lumbar spine surgery, joint replacement or scoliosis among others, as well as sacroiliac joint pain, which is estimated to affect between 15–30% of individuals with chronic low back pain.
Kevin Kenny, global president of Orthofix Spine, says: “The clearance of the nanotechnology feature gives us the opportunity to educate surgeons about the unique benefits of the system’s nano-surface.”
This specific system is implanted through a minimally invasive procedure that involves inserting two to four bone screws across the SI joint to stabilise the joint during the fusion process.
Its 3D-printed mid-shaft porous region is designed to allow for bone through growth through the device to aid in the fusion process for patients being treated for pain and dysfunction of the SI joint.
It also features a cannulated screw design, which enables surgeons to pack the device with autograft and/or allografts to help promote bone fusion.
The FIREBIRD SI Fusion System is the latest from Orthofix Spine, which also offers allograft solutions such as the Trinity ELITE allograft.