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www.fdanews.com/articles/206488-kuros-biosciences-magnetos-granules-for-spine-get-510k-clearance

Kuros Biosciences’ MagnetOs Granules for Spine Get 510(k) Clearance

February 8, 2022

Bone graft technology company Kuros Biosciences’ MagnetOs granules have been cleared by the FDA for standalone use in spinal fusion procedures.

The FDA clearance was based on positive data from a 50-participant trial in which the granules were compared head-to-head against autograft, the gold standard for posterolateral lumbar spinal fusion.

The clearance for standalone use means that MagnetOs can be used in place of, as well as in combination with, autograft bone, the company said.

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