SI-Bone receives FDA 510k clearance for smaller diameter of iFuse Implant

SI-BONE announces FDA 510(k) premarket clearance of the iFuse Bedrock Granite Implant System in a smaller 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.