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Pedicle screw final rule

This article was originally published in The Gray Sheet

Executive Summary

FDA downclassifies to Class II the postamendments Class III pedicle screw spinal systems for spinal stabilization as an adjunct to fusion for certain patient populations, according to a final rule published in the Federal Register July 27. Unclassified preamendments systems intended for treatment of severe spondylolisthesis in certain patients are classified into Class II. Pedicle screw spinal systems intended for any other uses are considered postamendments Class III devices requiring premarket approval, FDA says. The rule takes effect Aug. 26



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