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FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems
Date:10/5/2009

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Traditional, rigid stabilization systems have been on the market for decades, and provide stability via screws inserted into segments of the spine. The screws act as anchors that are then connected by uniform metallic rods, which immobilize the spinal segments and facilitate fusion. These systems are not intended to allow motion.

When intended as stabilizers during bone fusion, this type of device is class II and is subject to FDA's premarket notification requirement (also known as 510(k)). Devices subject to this requirement are cleared for marketing in the United States if FDA finds them to be substantially equivalent to legally marketed predicate devices.

The FDA cleared the first dynamic stabilization system component in 1997. The FDA has cleared numerous dynamic stabilization systems or components since then. FDA has only ordered postmarket surveillance studies for the class II dynamic stabilization systems and components, which are intended for bone fusion.

The FDA has required the manufacturers of 16 dynamic stabilization systems or components on the market for spinal fusion to conduct postmarket surveillance studies, which must address the following:

  • the fusion rate for dynamic stabilization systems compared to traditional stabilization systems;
  • the incidence rate, severity, and time course of adverse events for dynamic stabilization systems compared to traditional stabilization systems;
  • the type, incidence rate, and time course of subsequent surgical procedures for dynamic stabilization systems compared to traditional stabilization systems; and
  • the cause of failure for dynamic stabilization systems based on analysis of all reasonable available systems that have been removed from patients, along with any association between the patient's demographic and clinical data and the device failure.

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SOURCE U.S. Food and Drug Administration
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