{"abstract":"The Food and Drug Administration (FDA or Agency) is proposing to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately proposing to require the filing of a premarket approval application (PMA). FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device. FDA is publishing this proposed rule based, in part, on the recommendations of the Orthopaedic and Rehabilitation Devices Panel, regarding the classification of spinal spheres for use in intervertebral fusion procedures.","action":"Proposed rule.","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/2021/12/15/2021-27137.html","cfr_references":[{"chapter":null,"citation_url":null,"part":888,"title":21}],"citation":"86 FR 71191","comment_url":null,"comments_close_on":"2022-03-15","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by March 15, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0310"],"dockets":[{"supporting_documents":[{"title":"Reference 3 - Proposed Regulatory Impact Analysis","document_id":"FDA-2021-N-0310-0012"},{"title":"Reference 2 - Failure_of_the_Fernstrom_ball_in_contemporary.20","document_id":"FDA-2021-N-0310-0011"},{"title":"Reference 1 - H - FDA Spinal Spheres Presentation","document_id":"FDA-2021-N-0310-0010"},{"title":"Reference 1 - G - Dec  12 2013 - Questions for Panel","document_id":"FDA-2021-N-0310-0009"},{"title":"Reference 1 - F - FDA Spinal Spheres Panel Questions","document_id":"FDA-2021-N-0310-0008"},{"title":"Reference 1 - E - Master Slide Device Classification Panel - revised for 2013.12.12 meeting","document_id":"FDA-2021-N-0310-0007"},{"title":"Reference 1 - D - Spinal Spheres Devices Roster","document_id":"FDA-2021-N-0310-0006"},{"title":"Reference 1 - C - Transcript Orthopaedic and Rehabilitation Devices Panel of 12-12-13","document_id":"FDA-2021-N-0310-0005"},{"title":"Reference 1 - B - Executive Summary - Spinal Spheres PANEL","document_id":"FDA-2021-N-0310-0004"},{"title":"Reference 1 - A - 24 hr OR 121213","document_id":"FDA-2021-N-0310-0003"}],"agency_name":"FDA","documents":[{"comment_count":2,"comment_start_date":"2021-12-15","updated_at":"2023-02-28T12:35:07.621-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0310-0001","allow_late_comments":null,"id":"FDA-2021-N-0310-0001","comment_end_date":"2022-03-16","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":11,"id":"FDA-2021-N-0310","title":"Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures; Request for Comments"}],"document_number":"2021-27137","effective_on":null,"end_page":71196,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/12/15/2021-27137.xml","html_url":"https://www.federalregister.gov/documents/2021/12/15/2021-27137/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-27137?publication_date=2021-12-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-12-15/2021-27137/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":912,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-12-15/pdf/2021-27137.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-27137.pdf?1639489539","publication_date":"2021-12-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/12/15/2021-27137.txt","regulation_id_number_info":{"0910-AI32":{"issue":"202210","html_url":"https://www.federalregister.gov/regulations/0910-AI32/classification-of-spinal-spheres-for-use-in-intervertebral-fusion-procedures","title":"Classification of Spinal Spheres For Use in Intervertebral Fusion Procedures","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0910-AI32&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AI32"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 3 - Proposed Regulatory Impact Analysis","document_id":"FDA-2021-N-0310-0012"},{"title":"Reference 2 - Failure_of_the_Fernstrom_ball_in_contemporary.20","document_id":"FDA-2021-N-0310-0011"},{"title":"Reference 1 - H - FDA Spinal Spheres Presentation","document_id":"FDA-2021-N-0310-0010"},{"title":"Reference 1 - G - Dec  12 2013 - Questions for Panel","document_id":"FDA-2021-N-0310-0009"},{"title":"Reference 1 - F - FDA Spinal Spheres Panel Questions","document_id":"FDA-2021-N-0310-0008"},{"title":"Reference 1 - E - Master Slide Device Classification Panel - revised for 2013.12.12 meeting","document_id":"FDA-2021-N-0310-0007"},{"title":"Reference 1 - D - Spinal Spheres Devices Roster","document_id":"FDA-2021-N-0310-0006"},{"title":"Reference 1 - C - Transcript Orthopaedic and Rehabilitation Devices Panel of 12-12-13","document_id":"FDA-2021-N-0310-0005"},{"title":"Reference 1 - B - Executive Summary - Spinal Spheres PANEL","document_id":"FDA-2021-N-0310-0004"},{"title":"Reference 1 - A - 24 hr OR 121213","document_id":"FDA-2021-N-0310-0003"}],"comments_count":2,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-0310","supporting_documents_count":11,"docket_id":"FDA-2021-N-0310","document_id":"FDA-2021-N-0310-0001","regulation_id_number":null,"title":"Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures; Request for Comments","checked_regulationsdotgov_at":"2023-03-31T14:00:15Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":71191,"subtype":null,"title":"Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures","toc_doc":"Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures","toc_subject":"Medical Devices:\n","topics":["Medical devices"],"type":"Proposed Rule","volume":86}