SI-BONE Gains FDA 510(k) for iFuse Bedrock Granite

By Julie A. Vetalice

SI-BONE Gains FDA 510(k) for iFuse Bedrock Granite

SI-BONE was granted FDA 510(k) clearance to market the iFuse Bedrock Granite Implant System. The Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion.

This clearance follows an earlier designation by FDA of Granite as a Breakthrough Device, and most recently, a proposal by the Centers for Medicare and Medicaid Services for a New Technology Add-on Payment. CMS has 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.

“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,” said Laura Francis, CEO of SI-BONE.

Source: SI-BONE, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory