SIBN SI-BONE Inc

SI-BONE announced that the FDA granted 510(k) clearance for its iFuse Granite Onyx system, its first product designed for compromised bone outside the pelvis, expanding the company’s addressable market beyond its existing pelvic applications. Onyx targets screw loosening in the upper and lower instrumented vertebrae of spinal fusion constructs, an issue occurring in up to 27% of fusion procedures and more frequently in patients with low bone density. The system features a bone-density-specific surface and anatomy-specific thread design intended to promote rapid osseointegration, reduce micromotion, improve early fixation and limit screw loosening. CEO Laura Francis said Onyx is SI-BONE’s third platform designated as a Breakthrough Device. Since 2009, the company has supported more than 150,000 procedures. $SIBN