FDA Clears SI BONE’s Latest SI Fusion Innovation

The FDA has cleared six additional posterior spinal fixation rods for use as pelvic implant devices.

The agency’s 510(k) clearances covered six variations on the iFuse Bedrock Granite^® Implant System. The system is intended for sacroiliac joint fusion for the following conditions:

• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Silicon Valley-based SI-BONE, Inc. submitted the device for 510(k) clearance. With clearance, the device now has expanded compatibility. SI-BONE recently announced that “certain CD Horizon^® Solera^® 5.5mm and 6.0mm posterior spinal fixation rods manufactured by Medtronic Sofamor Danek USA Inc., a division of Medtronic plc, meet SI-BONE’s criteria for compatibility.”

According to SI-BONE, the following Medtronic CD Horizon Solera rods meet iFuse Bedrock Granite implant compatibility criteria:

• CD HORIZON SOLERA Ø5mm Lined Titanium Alloy Straight Rod, length = 500mm
• CD HORIZON SOLERA Ø0mm Lined Titanium Alloy Straight Rod, length = 500mm
• CD HORIZON SOLERA Ø5mm Lined CHROMALOY Straight Rod, length = 500mm
• CD HORIZON SOLERA Ø5mm Lined CHROMALOY Plus Straight Rod, length = 600mm
• CD HORIZON SOLERA Ø0mm Lined CHROMALOY Straight Rod, length = 500mm
• CD HORIZON SOLERA Ø0mm Lined CHROMALOY Plus Straight Rod, length = 500mm

SI-BONE CEO Laura Francis said, “Given the strong initial reception for Granite, we are thrilled to confirm that a number of Medtronic’s Solera^® rods, used by many spine surgeons, meet Granite’s compatibility criteria.”

Francis continued, “Our existing general rod compatibility clearance, along with confirmation that these Medtronic Solera rods meet the criteria for compatibility with the Granite implant will give spine surgeons additional confidence in using our leading pelvic fixation implant with the Medtronic Solera system.”