On May 22, 2001, the FDA issued a technical amendment to its 1998 ruling. In this amendment, the FDA noted that lateral mass and pedicle screw systems in the cervical spine were in use before 1976 and should instead be considered pre-amendment Class III devices instead of post-amendment Class III devices. This ruling subjected cervical spine pedicle screw systems to specific regulations such as requiring 510(k) premarket notifications [20].

Eight years later, on April 9, 2009, the FDA published an order under Sect. 515(i) of the FD&C Act (21 U.S.C. 360i) calling for additional information on the remaining Class III 510(k) pre-amendment devices including the thoracolumbosacral pedicle screw spinal systems [21]. However, the classification of posterior cervical screws was deferred due to a lack of prior input from the FDA advisory panel. Responses to this 515(i) order concerning thoracolumbosacral spinal systems unanimously supported Class II designation with assurances provided by special controls such as labeling, biocompatibility, sterility, and mechanical testing [21]. This was an important advancement because Class II devices are deemed lower risk than Class III devices, and therefore, can be more readily used in patient care. Additionally, designation from Class III to Class II has the potential to improve insurance coverage of certain procedures, making them more accessible to patients.

In May 2010, the Orthopedic Surgical Manufacturers Association (OSMA) responded to the 515(i) order with a petition declaring that posterior screws, particularly pedicle screws, should be deemed Class II devices for use in degenerative disc disease, pediatrics, and the posterior cervical spine [22]. In November 2010, the AANS and CNS also submitted comments in support of the OSMA petition. In this letter, the organizations pointed to the challenges of the growing off-label use of cervical pedicle screw spinal devices, including medical liability for surgeons, inappropriate denial of insurance coverage, and published lack of trust in the validity of use and cost [22]. The inclusion of data regarding posterior cervical screws from OSMA and others was outside the scope of the original 2009 FDA “call for information.” The topic of posterior cervical pedicle screw systems had yet to be formally addressed in a classification panel meeting and it was required that a panel be convened per Sect. 513(b) of the FD&C Act [23]. Therefore, the FDA requested that OSMA prepare and submit a separate petition for classification.

In November 2011, OSMA submitted a petition for lateral mass and pedicle screw spinal systems to be moved to a Class II designation. In this petition, OSMA sought to reclassify cervical pedicle screw systems at levels C1 to T3 as Class II due to the ability of the general and special controls to provide a reasonable assurance of safety and effectiveness [22]. The petition included a literature search of cervical spine pedicle screw systems in practice (including data from 1999 to 2009) and identified that such systems offered patients improved or preserved neurological function, improvements in pain/discomfort, and higher fusion rates when compared to already Class II-designated cervical spinal sublaminar hooks, sublaminar cables, and interspinous process wiring [22].

On August 28, 2012, a panel from the AANS/CNS submitted another letter with comments regarding lateral mass and pedicle screw spinal system classification in response to the FDA Orthopedic and Rehabilitation Devices Panel meeting of the medical devices advisory committee (MDAC) [24]. This letter emphasized the anatomical and biomechanical advantages of posterior cervical screws in comparison to FDA-approved devices and pointed to many studies that supported their safety and utility. They emphasized that pedicle screws used in the posterior cervical spine were widely considered standard of care and called for Class II designation for posterior cervical lateral mass and pedicle screw systems [24].

In September 2012, the FDA consulted with the Orthopedic and Rehabilitation Devices Panel FDA advisory committee regarding posterior cervical pedicle and lateral mass screw spinal systems. Based on their expertise and historical data, the panel noted effective posterior cervical pedicle and lateral mass screw spinal systems were in use as adjuncts to fusion for acute and chronic instabilities of the cervical spine and craniocervical junction [23]. The panel did express concerns regarding a lack of long-term data and the need for additional data on specific screw types. At the meeting’s conclusion, an unofficial vote by the panel was in favor of posterior cervical pedicle and lateral mass screw spinal systems to be designated as Class II devices [25]. In May 2013, the same panel convened and recommended that rigid pedicle screw systems have an additional Class II designation when used in the thoracic, lumbar, and sacral spines as adjuncts to fusion for degenerative disc disease and spondylolisthesis (other than either severe spondylolisthesis grade 3 or 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment). In support of their recommendation, the panel included a summary of safety and effectiveness information, a literature review, and a review of adverse event reports from the Manufacturer and User Facility Devices Experience (MAUDE) database [26].