CDRH Industry: FDA Makes Correction to Compliance Date for Reclassification of Thoracolumbosacral Pedicle Screw Systems

On January 9, 2017, the Food and Drug Administration (FDA) published in the Federal Register a correction to the final order, “Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, including Semi-Rigid Systems” that was originally issued on December 29, 2016.  The correction indicates that manufacturers of Semi-Rigid Systems (SRS) currently on the market must comply with the special controls outlined in the final order by July 1, 2019. 

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

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