FDA Clears One Ortho 2D Hip Planning Software

FDA 510(k) clearance granted to One Ortho's 2D Hip Planning Software (product code LLZ), a radiology-based tool for preoperative hip surgical planning from 2D imaging.

• Cleared under FDA 510(k) pathway, product code LLZ, classified under radiology devices — indicates substantial equivalence to a predicate device.
• Software supports 2D preoperative planning for hip procedures, intended for use with standard radiographic imaging.
• No clinical performance data (sensitivity/specificity, AUC) reported in the clearance summary; regulatory clearance does not constitute evidence of superiority over existing planning tools.

Automated summary

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