| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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FR Recognition Number
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11-434
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| Standard | |
ASTM F3018-25
Standard Guide for Assessment of Hard-on-Hard Articulation in Total Hip Joint Replacement and Resurfacing Hip Joint Replacement |
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Scope/Abstract1.1 This guide covers materials and design recommendations and general test methods for the mechanical and preclinical assessment of implantable devices with hard-on-hard articulations intended to replace a hip joint. The provided guidance is intended to encompass both total hip joint replacements as well as resurfacing hip joint replacement (RS). There has been long-term clinical experience with metal-on-metal articulating components manufactured from cobalt-28chromium-6molybdenum (Co-28Cr-6Mo) alloy (as specified in ASTM F75, F799, or F1537) and ceramic-on-ceramic articulating components manufactured from alumina-based ceramics (as specified in ISO 6474-1 or ISO 6474-2). This guide has been created based on the current understanding derived from those clinical histories. Implant articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified articulating surfaces could also be evaluated with this guide. However, such materials that do not have a history of clinical use may present different risks.
1.2 This guide applies to the acetabular and femoral articulating components of hard-on-hard hip joint replacements. Acetabular components can be monobloc, or a modular component with a separate cup and liner. As stated above, articulating components have been made from Co-28Cr-6Mo for a metal-on-metal bearing; and alumina-based ceramics for a ceramic-on-ceramic bearing. Cups of modular acetabular components have to date been made from Ti-6Al-4V (as specified in ASTM F136 or F1472, or ISO 5832-3) or Co-28Cr-6Mo. The shell is considered part of the acetabular component. Acetabular components may have an external coating and/or porous structure intended for uncemented, press-fit or biological fixation, or for use with bone cement.
1.3 This guide is a summary of available specifications, test methods, practices, and guides from published standards or the scientific literature. Their clinical relevance is unproven. Most of the methods do not have an established precision and bias; therefore, their repeatability and reproducibility have not been established. As the clinical relevance of these methods have not been established, consequently, most do not have performance requirements. This document does not require that all the listed methodologies are always necessary to evaluate these implant systems provided justification for not using each unused method is provided. This document does not intend to prevent the use of new methodologies as they are developed. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
| FDA recognition of ASTM F3018-17 [Rec# 11-340] will be superseded by recognition of ASTM F3018-25 [Rec# 11-434]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-340] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 11-340] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.3320 |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
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Class 3
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JDL
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| §888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
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Class 3
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KWA
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| §888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer
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Class 3
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KXB
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| §888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
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Class 3
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OCG
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| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented |
Class 3
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LPF
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| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3
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MRA
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| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing |
Class 3
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NXT
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Prostheses, issued September 2007.
Guidance Document for the Preparation of Premarket Notification For Ceramic Ball Hip Systems, issued January 1995.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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