SI-BONE, Inc. Receives FDA 510(k) Clearance for a Smaller Diameter iFuse Bedrock Granite Implant with an Expanded Indication and Application

SI-BONE, Inc. announces FDA 510(k) premarket clearance of the iFuse Bedrock Granite® Implant System (Granite) in a smaller (9.5 mm) diameter with both an expanded indication in pediatric patients and an expanded application that includes use in the S1 trajectory. When placed across the SI joint, the Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundational element for multi-segment spinal fusion. This 510(k) clearance follows the initial clearance of the iFuse Bedrock Granite System in May 2022 that included implants of 10.5 mm and 11.5 mm in diameter.

The iFuse Bedrock Granite System was also awarded a Breakthrough Device Designation (BDD) by the Food & Drug Administration (FDA) and a New Technology Add-on Payment (NTAP) by the Centers for Medicare and Medicaid Services (CMS).