SI-BONE, Inc., a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announced an additional FDA clearance for iFuse Bedrock Granite. New cleared indications include use with a wide variety of commercially available pedicle screw system rods.
Adult spinal deformity is a complex clinical problem to treat, with lumbopelvic fixation failure rates reported at 24%. Surgeons have adopted different strategies involving preoperative planning to improve spinal alignment, biologics, and next-generation pelvic fixation implants to help improve surgical outcomes. SI-BONE introduced iFuse Bedrock Granite in May 2022 to address some of these issues. The implant is typically used both to immobilize and fuse the sacroiliac (SI) joint and to serve as foundational support at the base of a spine fusion construct. The initial clearance included an indication for use with a single manufacturer
