Santa Clara, Calif.-based SI-BONE received FDA 510(k) clearance for its iFuse Granite Onyx System, a spinal fusion technology designed for patients with compromised bone tissue.
The system is SI-Bone’s first product addressing compromised bone intended for use outside the pelvis, according to a Sept. 28 news release.
The technology is designed to address loosening at the upper and lower instrumented vertebrae of a spinal fusion construct. Loosening occurs in as many as 27% of fusion constructs.
SI-Bone said Onyx is its third platform designated as a breakthrough device. The company has supported physicians in performing over 150,000 procedures since 2009.
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