FDA-OSDB has collaborated with SI-BONE to arrive at a more accurate description of the intended use of the iFuse System.
Based upon internal discussions, as well as a review of the medical literature related to SI joint disease and associated clinical care, FDA agreed to remove ‘fracture’ from the indications for use and to further modify the indications for use statement as follows: ‘ The SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, as the agency believed this is more in line with the true intent of SI Joint Fusion System.’
SI-BONE CEO Jeff Dunn said this approval from the agency provides them with a significant advantage in getting the word out on appropriate diagnosis of low back complaints that include the SI joint and that an MIS option for patients with SI joint problems and provides with a unique opportunity to teach spine surgeons about the iFuse Implant System for SI joint fixation/fusion.
SI-BONE received FDA approval in November 2008 and CE mark for European commercialization in November 2010.
The iFuse Implant System procedure uses a minimal incision for delivery and implantation of small, titanium implants.
The implants are coated with a porous plasma spray that acts as an interference surface, designed to help decrease implant motion.
