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Semi-Rigid Spine Systems Will Escape PMAs, But Not Clinical Mandate

Executive Summary

US FDA has completed a long-running effort to reclassify pedicle screw systems, which are widely used devices for spine fusion procedures. The final policy: all pedicle screws intended as an adjunct to fusion surgery are class II/special controls devices, but "semi-rigid" systems will require clinical data to support 510(k) clearance while more traditional, rigid systems will not.

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Industry Urges FDA To Downclassify PEEK Rods For Spinal Fusion

PEEK, or polyether ether ketone, rods should be set as class II devices along with metallic, rigid pedicle screws, rather than put to class III with dynamic spine stabilization systems, companies say, responding to an FDA proposed order.

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