Si-Bone announced today that it received FDA 510(k) clearance for its iFuse Bedrock Granite implant system for spinal procedures.
Santa Clara, California-based Si-Bone designed the iFuse “Granite” implant to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion.
According to a news release, FDA clearance follows earlier breakthrough device designation for the Granite implant, as well as a Centers for Medicare and Medicaid Services (CMS) proposal for a new technology add-on payment (NTAP). CMS also issued new technology “Section X” ICD-10 unique procedure coding for hospitals to report NTAP eligible cases that use Granite as an internal fixation device with tulip connector for either open or percutaneous sacroiliac joint fusion and sacropelvic fixation.
Duke University Spine Division Chief Dr. Christopher Shaffrey said in the release that Granite offers a device “designed for the specific demands of the sacropelvic anatomy.”
“We are thrilled to receive FDA 510(k) clearance to launch Granite to the market. The anticipation has been building ever since the FDA awarded BDD for its promise of providing more effective treatment than the current standard of care, and CMS’ recently proposed NTAP, recognizing it as a new technology that can provide substantial clinical improvement over already available therapies,” Si-Bone CEO Laura Francis said in the release. “Based on the early pre-clinical data from in vivo animal studies suggesting significant bone ingrowth and superior mechanical stability, internal studies showing markedly improved biomechanics, and initial feedback from surgeons, we couldn’t be more enthusiastic about Granite’s clinical and commercial promise as a uniquely disruptive technology.”