Semi-Rigid Spine Systems Will Escape PMAs, But Not Clinical Mandate
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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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.
The agency proposes to maintain 510(k) standards for rigid pedicle screw systems but wants dynamic spine stabilization devices, designed to provide more motion and flexibility, to go the PMA route.
FDA should not approve Zimmer's Dynesys spine stabilization system as a stand-alone treatment for degenerative spine-related leg pain due to insufficient safety and efficacy data, according to the agency's Orthopedic and Rehabilitation Devices Panel