SI-Bone earned FDA 510(k) clearance of the iFuse Bedrock Granite implant system in a smaller diameter, according to a Jan. 30 news release.
The clearance also applies to an expanded indication in pediatric patients and use in the S1 trajectory. the company said. The implant is designed for sacroiliac fusion and sacropelvic fixation.
In 2022, the iFuse Bedrock Granite system earned its initial clearance. It also has the FDA’s Breakthrough Device Designation and a New Technology Add-on Payment from CMS.
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