{"abstract":"The Food and Drug Administration (FDA) is denying the petition submitted by the Orthopedic Surgical Manufacturers Association (OSMA) to reclassify the hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component and the hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component from class III (premarket approval) into class II (special controls). The agency is denying the petition because OSMA failed to provide any new information to establish that special controls would provide reasonable assurance of the safety and effectiveness of the devices. The agency is also publishing the recommendation of FDA's Orthopedic and Rehabilitation Devices Panel (the Panel) concerning the petition. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).","action":"Notice; denial of petition.","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/2002/09/06/02-22688.html","cfr_references":[],"citation":"67 FR 57024","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. 01P-0343"],"dockets":[],"document_number":"02-22688","effective_on":null,"end_page":57026,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2002/09/06/02-22688.xml","html_url":"https://www.federalregister.gov/documents/2002/09/06/02-22688/orthopedic-devices-denial-of-request-for-change-in-classification-of-hip-joint-metalmetal","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/02-22688?publication_date=2002-09-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2002-09-06/02-22688/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":47,"last_updated":"2026-04-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2002-09-06/pdf/02-22688.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2002-09-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2002/09/06/02-22688.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":57024,"subtype":null,"title":"Orthopedic Devices; Denial of Request for Change in Classification of Hip Joint Metal/Metal Semi-Constrained, With a Cemented Acetabular Component, Prosthesis and Hip Joint Metal/Metal Semi-Constrained, With an Uncemented Acetabular Component, Prosthesis","toc_doc":"Orthopedic devices; hip joint metal/metal semi-constrained prostheses; reclassification from class III to class II; petition denied","toc_subject":"Medical devices:","topics":[],"type":"Notice","volume":67}