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This article was originally published in The Gray Sheet

Executive Summary

PEDICLE BONE SCREW RETROSPECTIVE STUDY is being developed through a cooperative effort between FDA spinal implant manufacturers and medical professional societies. The study is intended to collect clinical data on the safety and efficacy of the devices. Industry hopes that the study results will be sufficient to support reclassification of pedicle bone screws from Class III to Class II, or if not, that they will at least provide control data for a prospective study of the devices. The retrospective study likely will be funded and managed by the Spinal Implant Manufacturers Group, a coalition of spinal implant manufacturers that recently banded together to seek reclassification of pedicle bone screws. SIMG is an outgrowth of a group of five pedicle bone screw manufacturers that asked FDA to downclassify the devices last summer ("The Gray Sheet" Sept. 7, 1992, p. 9). Currently comprised of 14 companies, the group officially formed on June 15 following a meeting between representatives of FDA, manufacturers and professional medical societies to discuss pedicle bone screws. The SIMG members are: AcroMed, Ace Medical, Acufex Microsurgical, Aesculap, Advanced Spine Fixation Systems, American Medical Electronics, Advanced Med/Surg, Cross Medical Products, Sofamor/Danek Group, Electro-Biology, Osteotech, Smith & Nephew Richards, Stryker and Synthes. The retrospective study was a focal point of discussion at the June 15 meeting, which was attended by over 20 spinal implant manufacturers and representatives from three medical groups: the American Academy of Orthopedic Surgeons, the North American Spine Society and the Scoliosis Research Society. A subgroup of the June 15 meeting attendees gathered again on July 9 to work on the retrospective study, particularly the case report forms. The retrospective study is tentatively on the agenda for discussion at the Aug. 20 meeting of FDA's orthopedic and rehabilitation devices panel. The panel is not expected to address regulatory questions related to pedicle bone screws. Rather, the meeting is intended to be an open scientific exchange on the safety and efficacy of the devices. In the downclassification request made last summer, Advanced Bioresearch Associates, regulatory counsel for the five manufacturers as well as SIMG, pointed out that pedicle bone screws are the only bone screws regulated in Class III. Noting that the devices are on the market under the guise of "bone screws, sacral screws, or...anterior spinal screws," the group maintained that safety of pedicle bone screws "is not an issue" and that FDA should allow the products to enter the market via the 510(k) process instead of requiring premarket approval applications. ABA also argued that widespread availability of the devices would make it difficult to conduct "well-designed clinical studies."

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