SI-BONE announced FDA 510(k) clearance of the iFuse Bedrock Granite Implant in a 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, Granite provides sacroiliac fusion and sacropelvic fixation as a foundational element for multi-segment spinal fusion.
This follows the initial clearance of the system in 2022 that included implants of 10.5 mm and 11.5 mm in diameter. iFuse Bedrock Granite was also awarded a Breakthrough Device Designation and a New Technology Add-on Payment by the Centers for Medicare and Medicaid Services.
SI-BONE announced FDA 510(k) clearance of the iFuse Bedrock Granite Implant in a 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, Granite provides sacroiliac fusion and sacropelvic fixation as a foundational element for...
SI-BONE announced FDA 510(k) clearance of the iFuse Bedrock Granite Implant in a 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, Granite provides sacroiliac fusion and sacropelvic fixation as a foundational element for multi-segment spinal fusion.
This follows the initial clearance of the system in 2022 that included implants of 10.5 mm and 11.5 mm in diameter. iFuse Bedrock Granite was also awarded a Breakthrough Device Designation and a New Technology Add-on Payment by the Centers for Medicare and Medicaid Services.
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