SI-BONE Launches iFuse Bedrock Granite 9.5mm Implant; Completes 1st Surgeries

SI-BONE has completed the first procedures using its smaller, 9.5 mm diameter iFuse Bedrock Granite implant (Granite 9.5).
 
This milestone for Granite 9.5 follows a U.S. Food and Drug Administration (FDA) 510(k) nod in January 2024. The implant was also granted FDA breakthrough status and a New Technology Add-on Payment by the Centers for Medicare and Medicaid Services.
 
When placed across the SI (sacroiliac) joint, the Granite implant offers SI fusion and spinopelvic fixation as a foundation element for multi-segment spinal fusion, according to the company. The company also said Granite 9.5 might be more appropriate for patients with smaller anatomy, allowing easier stacked implant placement in the sacroalar-iliac trajectory.
 
The recent FDA clearance also covers use in the sacrum’s S1 body and pediatric deformity.
 
“The addition of Granite 9.5 and shorter lengths worked seamlessly in helping me revise failed S1 screws,” said Victor Chang, MD, a neurosurgeon at Henry Ford Health in West Bloomfield, Michigan. “The S1 Granite 9.5 implants were a welcome addition to the 10.5 mm Granite implants I use for sacroalar-iliac fixation in my constructs. I’m very excited to have the additional sizes available as it will allow more opportunities to incorporate robust fixation with Granite into my cases.”
 
“Granite has been a resounding success for us since the product was launched in 2022. It allowed us to target an exciting billion-dollar market by addressing a significant unmet clinical need at the foundation of multi-segment spinal fusion procedures,” added Laura Francis, SI-BONE’s CEO. “Given the surgeon enthusiasm around the smaller diameter implant, we are poised to accelerate the adoption of Granite across the nearly 130,000 annual adult deformity and degenerative spine target procedures.”