SI-BONE : FDA Clears Expanded Rod Compatibility With IFuse Bedrock Granite Implant System

(RTTNews) - SI-BONE Inc. (SIBN) 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.

The initial clearance included an indication for use with a single manufacturer's pedicle screw system. The expanded indications include use with a wide range of rods that are commonly used in multilevel spine fusion surgeries. The expanded indications will allow surgeons to use their preferred techniques and implant systems with confidence in conjunction with iFuse Bedrock Granite as the foundation for their construct.

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 company said in a statement.