SI-BONE Gets FDA Clearance for Its iFuse Bedrock Granite for Spinal Treatment
Santa Clara, Calif.-based SI-BONE has been granted 510(k) premarket clearance by the FDA for its iFuse Bedrock Granite implant system.
The implant, which provides sacroiliac fusion and sacropelvic fixation for spinal fusion procedures, previously received the FDA’s Breakthrough Device designation, as well as a proposal by the Centers for Medicare and Medicaid Services for a new technology add-on payment.
Use of the implant “should lead to fewer reoperations, better patient outcomes, and less cost to the system,” according to Scott Alexander, former vice president of innovation at Mercy Health System, who assessed the product.
SI-BONE specializes in musculoskeletal disorders of the sacropelvic anatomy.