ASTM F2033-12

Standard Organization:

ASTM F2033-12
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Mateirals

Recognition Date2014-01-30
Recognition List034
Recognition Number11-238
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG Orthopedic
FDA Tech .stds { color: #000000; float: center; width: 950px; margin: 0px 25px 0px 0px; } .stds-middle { color: #000000; float: center; width: 575px; margin: 0px 50px 50px 50px; } /* .stds-left { float: left; margin: 9px 30px 0px 0; } */ .stds-left { color: #000000; float: left; width: 700px; margin: 9px 0px 0px 0px; } .stds-search-left { float: left; width: 610px; margin: 9px 30px 0px 0; } .stds-search-right { float: right; width: 190px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f9f9f3; border: 1px solid #b0b0b0; -webkit-border-radius: 6px; -moz-border-radius: 6px; border-radius: 6px; } .stds-right { color: #000000; float: right; width: 170px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f3f3f3; border: 1px solid #b0b0b0; border-radius: 6px; } .stds-intro { margin: 0px 0px 18px 0px; padding: 5px 12px 12px 12px; background-color: #e8eff5; border: 1px solid #b0b0b0; border-radius: 6px; } #stds_nr-form { margin-top: 18px; padding-top: 12px; border-top: 1px dashed #b0b0b0; } #stds-form { table-layout:fixed; width: 700px; font-size: 11px; border: 1px solid #b0b0b0; background-color: #f9f9f3; } #stds-form-title{ padding: 3px 3px 3px 3px; width: 100%; background-color: #e8eff5; border-bottom: 1px solid #b0b0b0; margin-top: 0px; } #stds-form-title-left { font-size: 13px; font-weight:normal; } #stds-form-title-right { /*float: right;*/ font-size: 11px; padding: 0px 0px 0px 500px; } #stds-form-results-right { /*float: right;*/ font-size: 11px; padding: 0px 0px 0px 600px; } #stds-search { height: 18px; margin: 0px; padding: 3px 10px; border: 1px solid #b0b0b0; font-size: 12px; color: #484138; } #stds-search:focus, #stds-search:hover { -webkit-box-shadow: 0 0px 6px rgba(0,0,0,.1); -moz-box-shadow: 0 0px 6px rgba(0,0,0,.1); box-shadow: 0 0px 6px rgba(0,0,0,.1); } #stds-results-number { margin-bottom: 12px; font-size: 10px; font-weight: bold; } #stds-results-table { margin-left:auto; margin-right:auto; text-align:left; padding: 0; border-collapse:collapse; table-layout:fixed; background-color: #f9f9f3; border-color: #b0b0b0; border-width: 0 0 1px 1px; border-style: solid; } #stds-results-table th { padding: 6px 12px; background-color: #f9f9f3; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; font-size: 12px; } #stds-results-table td { padding: 6px 12px; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; text-transform: capitalize; } #stds-results-table tr:nth-child(odd) { /* background-color: #f3f3f3; */ } .sort { float: right; margin: 0px 10px 0px 0px; padding: 0px 5px 5px 5px; } /* .sort { float: right; margin-top: 5px;} */ .sort a { color: #484138; } .sort a:hover { color: #0f2a8c; } Recognized Consensus Standards // Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Recognized Consensus Standards var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: unescape('mp_js_orgin_url'), init: function(){ if (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, getCookie: function(name){ var start=document.cookie.indexOf(name+'='); if(start < 0) return null; start=start+name.length+1; var end=document.cookie.indexOf(';', start); if(end < 0) end=document.cookie.length; while (document.cookie.charAt(start)==' '){ start++; } return unescape(document.cookie.substring(start,end)); }, setCookie: function(name,value,path,domain){ var cookie=name+'='+escape(value); if(path)cookie+='; path='+path; if(domain)cookie+='; domain='+domain; var now=new Date(); now.setTime(now.getTime()+1000*60*60*24*365); cookie+='; expires='+now.toUTCString(); document.cookie=cookie; }, switchLanguage: function(lang){ if(lang!=MP.SrcLang){ var script=document.createElement('SCRIPT'); script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); document.body.appendChild(script); } else if(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ var script=document.createElement('SCRIPT'); script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); document.body.appendChild(script); } return false; }, switchToLang: function(url) { window.top.location.href=url; } }; var addthis_config = {data_track_clickback: true, ui_508_compliant: true, services_compact: 'facebook, twitter, linkedin, pinterest_share, email', services_exclude: 'print', image_container: "#user_provided" } ; FDA Home Medical Devices Databases -

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 This specification covers the requirements for the mating bearing surfaces of total hip prostheses and hip endoprostheses. More specifically, this specification covers hip joint replacement of the ball-and-socket configuration.

1.2 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical articulating metallic or ceramic femoral heads of total hip joint prostheses.

1.3 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical concave mating surface of metallic and ceramic acetabular components, including the inner polymeric bearing surface of bipolar heads, and the surface finish requirements and dimensional tolerances for the spherical concave mating surface of polymeric acetabular components.

1.4 This specification covers the sphericity and surface finish requirements for the spherical metallic or ceramic femoral heads of hip endoprostheses, and the outer bearing surface of bipolar heads.

1.5 This specification is intended for standard practice regarding the design of total hip joint bearing surfaces. Additionally, the tolerances imposed on the polymeric portion of the bearing surface are intentionally large due to temperature-induced changes and other manufacturing concerns. Some manufacturing methods or designs may intentionally reduce the diameter of the polymeric bearing to more closely mate with the diameter of the head.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§888.3390 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 KWY
§888.3360 Prosthesis, Hip, Femoral Component, Cemented, Metal Class 2 JDG
§888.3360 Prosthesis, Hip, Hemi-, Femoral, Metal Class 2 KWL
§888.3360 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Class 2 LWJ
§888.3360 Prosthesis, Upper Femoral Class 2 JDD
§888.3358 Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Class 2 OQG
§888.3358 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 MBL
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3353 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
§888.3350 Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Class 2 OQH
§888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class 2 JDI
§888.3340 Prosthesis, Hip, Semi-Constrained, Composite/Metal Class 2 KMC
§888.3330 Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 KWA
§888.3320 Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class 3 JDL
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class 2 KWZ
§888.3300 Prosthesis, Hip, Constrained, Metal Class 3 KXD
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented Class 3 LPF
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Class 3 MRA

FDA Guidance:

Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems, January 10, 1995

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.