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Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs

510(k)

SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis

MedDevice Startups Staff · 2 days ago · 2 min read · Via SI-BONE (GlobeNewswire)

FDA cleared SI-BONE's iFuse Granite Onyx system on September 28. The implant addresses loosening at the upper and lower instrumented vertebrae of a fusion construct, the two points that fail first when bone quality is poor. SI-BONE puts screw loosening at about 27 percent of constructs.

Onyx carried a Breakthrough Device designation before clearance. The design pairs a bone-density-specific surface with an anatomy-specific thread meant to cut micromotion and speed osseointegration. Han Jo Kim of Hospital for Special Surgery called loss of fixation from screw loosening an unmet clinical need.

This is the company's first compromised bone product above the pelvis, following iFuse Bedrock Granite at the base of the construct. SI-BONE has supported more than 150,000 procedures since 2009 and cites four randomized trials in its evidence base.

Questions & Answers

What is the SI-BONE iFuse Granite Onyx cleared for?

FDA cleared the SI-BONE iFuse Granite Onyx system on September 28, 2026 to address loosening at the upper and lower instrumented vertebrae of spinal fusion constructs, with an emphasis on patients with low bone density.

Did iFuse Granite Onyx have a Breakthrough Device designation?

Yes. SI-BONE's iFuse Granite Onyx carried an FDA Breakthrough Device designation before its September 28, 2026 510(k) clearance.

How common is screw loosening in spinal fusion?

SI-BONE cites screw loosening in roughly 27 percent of fusion constructs, with higher risk in patients with poor bone quality. That figure is the clinical case behind the iFuse Granite Onyx clearance.

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