FDA Clears Mighty Oak Medical Acorn 3D Spine Segmentation Software and Physical Model

FDA 510(k) clearance granted to Mighty Oak Medical for Acorn 3D Software (AC-SEG-4009) and Acorn 3DP Model (AC-101-XX), a spine segmentation and 3D-printed anatomical model system intended to support surgical planning.

• Cleared under product code QIH, which covers image segmentation and 3D-printed anatomical models derived from medical imaging data.
• The Acorn system combines software-based 3D segmentation of spinal anatomy with a corresponding physical 3D-printed model — both components cleared together under a single 510(k) (K260322).
• No clinical performance data (sensitivity, specificity, or accuracy figures) are reported in the clearance summary snippet; clinical validation details would require review of the full 510(k) submission.

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