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YOKNEAM, Israel, Jan. 25, 2021 /PRNewswire/ OrthoSpin Ltd. ( OrthoSpin ), announced today that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its second generation, robotic, digitally enabled external fixation system for orthopedic treatments.
OrthoSpin’s FDA-cleared Generation 2 robotic system enables automation of external fixation orthopedic treatments (credit: OrthoSpin).
External fixation devices are a common treatment choice for bone lengthening, setting complex fractures, and correcting deformities. Patient compliance challenges and a lack of real-time feedback for physician follow-up present substantial challenges. Currently, effective treatment necessitates that patients manually adjust fixation devices daily, requiring complicated patient training. This may cause adjustment errors and non-compliance, potentially resulting in poor clinical outcomes.