On March 10, the U.S. Food and Drug Administration (FDA) published a proposed rule to classify posterior cervical screw systems as a Class II device. Since posterior cervical screw systems were in use prior to May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), they are considered unclassified “pre-amendments devices” by the FDA, requiring premarket notification (510(k)). In 2011, the Orthopedic Surgical Manufacturers Association submitted a petition to the FDA to classify posterior cervical screw systems as a Class II device. In September 2012, the Orthopedic and Rehabilitation Devices Advisory Panel to the FDA agreed and recommended that these screw systems be classified as Class II. In the proposed rule issued on March 10, the FDA agreed with the Panel’s recommendation for classification of posterior cervical screw systems as Class II devices.
Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the issue of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance.
Pedicle screw spinal systems have been classified as Class II devices since July 1998.
The comment period for the proposed rule ends June 8, 2016. Read the full text of the proposed rule here.