CDRH Industry: FDA to Issue a Final Order for Reclassification of Thoracolumbosacral Pedicle Screw Systems

Today, the U.S. Food and Drug Administration (FDA) issued a final order “Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, including Semi-Rigid Systems.”  The FDA has determined that the risks to health from these devices are not substantially different from those associated with traditional rigid pedicle screw spinal systems.

Under this final order:

• Pedicle screw systems when used as an adjunct to spinal fusion procedures (product code NKB) are reclassified from class III, preamendment, to class II. Pedicle screw systems will be renamed to “thoracolumbosacral pedicle screw systems.”

• Dynamic stabilization systems, a subtype of pedicle screw systems, when used to maintain spinal stability during spinal fusion surgery are also reclassified from class III to class II with special controls. Dynamic stabilization systems will be renamed to “semi-rigid systems”.

• The device identification of pedicle screw systems will be clearly defined to distinguish between rigid pedicle screw systems and semi-rigid systems.

The 2013 Panel discussed the ability for clinical performance data to distinguish between successful and unsuccessful semi-rigid systems device designs. Based on comments received from the proposed order, analysis of the medical literature, and medical device reporting, the FDA believes there is sufficient information to establish clinical performance data as a special control. Clinical performance data along with other special controls and general controls provide a reasonable assurance of safety and effectiveness for semi-rigid systems.

Under the reclassification, manufacturers of currently legally marketed semi-rigid systems, for all indications, will need to submit a 510(k) amendment. Manufacturers with devices currently on the market must comply with the special controls outlined in the final order by June 30, 2019.  The 510(k) amendment requirement does not apply to rigid pedicle screw systems.

The FDA is issuing this final order as part of the 515 Program to ensure the appropriate regulation of Class III pre-amendments devices.

Once published, the final order can be found by searching for docket number FDA-2014-N-1205 on www.regulations.gov.

Food and Drug Administration
Center for Devices and Radiological Health