After years of off-label use, the FDA’s orthopedic panel finally recommended on May 22, 2013, that the FDA acknowledge what practioners are already doing and officially downclassify thoracolumbar pedicle screw spinal systems.
The devices are intended to treat degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1, or degenerative spondylolisthesis with objective evidence of neurologic impairment.
Dr. William Welch, on behalf of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS); Dr. Martin A. Yahiro, Director, Medical Affairs, NuVasive, Inc.; Dr. Susan Krasny, Past President and on behalf of the Orthopaedic Surgical Manufacturers Association (OSMA); and Dr. Jennifer Yttri, Senior Fellow and on behalf of the National Research Center for Women & Families addressed the Panel during the Open Public Hearing Session. The first three speakers concurred with FDA’s recommendation to downclassify. However, the last speaker suggested that FDA continue to regulate these products as Class III.
Pedicle screw spinal systems are one of the remaining pre-amendments class III devices, which means that they were marketed prior to the Medical Device Amendments of 1976. FDA originally classified them as the highest-risk Class III, but to date they’ve been approved for the U.S. market via the less-stringent 510(k) premarket notification process.
FDA staff recommended the down-classification based on data provided by some 20 manufacturers in response to a 2009 FDA request for information that safety and effectiveness of pedicle screws can be assured through non-clinical testing, material composition, sterilization validation and labeling.
The Panel also recommended that dynamic stabilization systems, a subset of pedicle screw spinal systems, remain as Class III, which translates into a call for PMAs (premarket approvals). The Panel also recommended that FDA remove skeletal maturity from the classification description and suggested that FDA refine the regulatory definition of degenerative disc disease.
The FDA will next consider the evidence and input from panel members, who essentially backed up all of FDA’s recommendations. The agency will then publish a proposed order, which will be open for public comments. After consideration of all additional comments, the agency will issue a final order to classify pedicle screws into a risk category.
If the agency then downclassifies the systems, these devices would continue to be subject to the premarket notification 510(k) requirements and any special controls specified in the final classification order. New pedicle screws and changes to existing devices that require a new submission to FDA would require a 510(k) demonstration that the special controls have been met, and a substantial equivalence determination.
