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SI-BONE gains FDA clearance for Onyx system targeting low-density bone

Sep 28, 2026, 4:19 PM EDT1 sourcesAI-analyzed

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Regulatory clearance for a new, density-specific spinal fixation system validates the platform and expands TAM, which typically supports a positive re-rating in the near term; however, actual revenue impact depends on adoption, reimbursement, and competitive dynamics.

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SI-BONE received FDA 510(k) clearance for the iFuse Granite Onyx System outside the pelvis, expanding its addressable market. Onyx targets UIV/LIV screw loosening in low-density bone with a bone-density specific design aimed at rapid osseointegration. The approval broadens the platform beyond Granite Bedrock and could drive near-term adoption and revenue upside.

FDA 510(k) clearance for iFuse Granite Onyx outside pelvis.
Onyx targets UIV/LIV screw loosening; loosening up to 27%.
3D-printed, bone-density specific design to speed osseointegration.
Expands SI-BONE market beyond Granite Bedrock platform.
Third SI-BONE breakthrough device designation.

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