SI-BONE Gets FDA OK for Smaller iFuse Bedrock Granite Implant

SI-BONE has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for a smaller (9.5 mm) diameter of its iFuse Bedrock Granite implant system. It has expanded indications for pediatric patients and an application that includes use in the S1 trajectory.
 
This FDA nod follows iFuse Bedrock Granite’s initial clearance in May 2022 with implant diameters of 10.5 mm and 11.5 mm. It was also awarded FDA breakthrough device status and a New Technology Add-on Payment (NTAP) by the Centers for Medicare and Medicaid Services (CMS).
 
When placed across the sacroiliac (SI) joint, the Granite implant provides SI fusion and sacropelvic fixation as a foundational element for multi-segment spinal fusion.
 
Greg Mundis, MD, an orthopedic spine surgeon at Scripps hospital, said there’s increased interest in the surgical community to include pelvic fixation in high-risk patients undergoing 2-3 level lumbar fusions. “The addition of a 9.5 mm diameter to the Granite product line now offers surgeons one of the more commonly used sizes to treat these patients,” he told the press.
 
Brian A. O’Shaughnessy, MD, Reconstructive Spinal Surgeon at Howell Allen Clinic in Nashville lauded being able to use the Granite implant at S1, “…a segment which published literature has shown to be one of the most challenging segments in the spine, with reported screw loosening rates ranging from 16-41%,” he said.
 
“The addition of a 9.5 mm diameter implant will seamlessly blend into my workflow, especially with both closed head and open head options,” added Chris Shaffrey, MD, Chief of the Spine Division at Duke University. “I’m very excited for patients to benefit from this breakthrough spinopelvic technology.”
 
In January 2023, the Granite implant gained FDA clearance to be used with various commercially available pedicle screw system rods.