{"abstract":"The Food and Drug Administration (FDA) is issuing a final order to reclassify pedicle screw systems, a preamendments class III device (regulated under product code NKB), into class II (special controls), renaming the device \"thoracolumbosacral pedicle screw systems\"; reclassify dynamic stabilization systems, a subtype of pedicle screw systems regulated under product code NQP when used as an adjunct to fusion, into class II (special controls), renaming this device subtype \"semi-rigid systems\"; and clarify the device identification of pedicle screw systems to more clearly delineate between rigid pedicle screw systems and semi-rigid systems. FDA is finalizing this action based on a reevaluation of information pertaining to the device type.","action":"Final order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/12/30/2016-31670.html","cfr_references":[{"chapter":null,"citation_url":null,"part":888,"title":21}],"citation":"81 FR 96366","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":["https://www.federalregister.gov/api/v1/documents/C1-2016-31670"],"dates":"This order is effective on December 30, 2016. See further discussion in section V, \"Implementation Strategy.\"","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1205"],"dockets":[],"document_number":"2016-31670","effective_on":"2016-12-30","end_page":96374,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/12/30/2016-31670.xml","html_url":"https://www.federalregister.gov/documents/2016/12/30/2016-31670/orthopedic-devices-reclassification-of-pedicle-screw-systems-henceforth-to-be-known-as","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-31670?publication_date=2016-12-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-12-30/2016-31670/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":3527,"last_updated":"2026-09-20 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-12-30/pdf/2016-31670.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-31670.pdf?1483019137","publication_date":"2016-12-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/12/30/2016-31670.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference  11 - Yang 2014 Short term outcome of posterior dynamic stabilization system in degenerative lumbar diseases re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, In","document_id":"FDA-2014-N-1205-0030"},{"title":"Reference 10.1 - Ormond 2012 Polyetheretherketone (PEEK) Rods in Lumbar Spine Degenerative Disease: A Case Series re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Includi","document_id":"FDA-2014-N-1205-0029"},{"title":"Reference  10 - Ormond 2016 Polyetheretherketone (PEEK) Rods in Lumbar Spine Degenerative Disease A Case Series re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including","document_id":"FDA-2014-N-1205-0028"},{"title":"Reference 9 - DeIure 2012 Posterior lumbar fusion by peek rods in degenerative spine: preliminary report on 30 cases re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Incl","document_id":"FDA-2014-N-1205-0027"},{"title":"Reference 8 - Colangeli 2015 Polyetheretherketone (PEEK) rods: short-term results in lumbar spine degenerative disease re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, In","document_id":"FDA-2014-N-1205-0026"},{"title":"Reference 7 - Athanasakopoulos 2013 Posterior Spinal Fusion Using Pedicle Screws re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems","document_id":"FDA-2014-N-1205-0025"},{"title":"Reference 6 - Gornet 2011 Biomechanical Assessment of a PEEK Rod System for Semi-Rigid Fixation of Lumbar Fusion Constructs re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw System","document_id":"FDA-2014-N-1205-0024"},{"title":"Reference 5 - Kurtz 2013 Retrieval analysis of PEEK rods for posterior fusion and motion preservation re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigi","document_id":"FDA-2014-N-1205-0023"},{"title":"Reference 4 - Sengupta 2013 The Comprehensive Biomechanics and Load-Sharing of Semirigid PEEK and Semirigid Posterio Dynamic Stabilizations Systems re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosac","document_id":"FDA-2014-N-1205-0022"},{"title":"Reference 3 - Qi 2013 Comparative effectiveness of PEEK rods versus titanium alloy rods in lumbar fusion: A preliminary report re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Sys","document_id":"FDA-2014-N-1205-0021"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-1205","supporting_documents_count":13,"docket_id":"FDA-2014-N-1205","regulation_id_number":null,"title":"Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems","checked_regulationsdotgov_at":"2017-01-19T06:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":96366,"subtype":null,"title":"Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems","toc_doc":"Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth to be known as Thoracolumbosacral Pedicle Screw Systems, including Semi-Rigid Systems","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":81}