SI-BONE Receives FDA 510(k) Clearance for iFuse Granite Onyx™, Extending Its Compromised Bone Franchise Beyond the Pelvis
SI-BONE announced it received FDA 510(k) clearance for its iFuse Granite Onyx implant, extending its compromised bone franchise beyond the pelvis. The platform, which received FDA Breakthrough Device Designation, is engineered for durable fixation in low-density bone.
Why it matters — FDA clearance expands SI-BONE's addressable product portfolio into new anatomical areas beyond its established pelvic franchise.