| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 12/18/2023
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FR Recognition Number
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11-403
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| Standard | |
ASTM F3047M-23
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations |
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Scope/Abstract1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6). |
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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 F3047M-15 [Rec# 11-303] will be superseded by recognition of ASTM F3047M-23 [Rec# 11-403]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-303] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 11-303] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.3300 |
Prosthesis, Hip, Constrained, Metal
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Class 3
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KXD
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| §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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| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented
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Class 3
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LPF
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| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
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Class 3
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MRA
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| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
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Class 3
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NXT
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| N/A |
Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
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Class 3
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OVO
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems, issued January 1995.
2. Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses, issued September 2007.
3. Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, issued April 1994.
4. Guidance for Industry and for FDA Reviewers/Staff - Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements, issued February 2000.
5. Guidance Document - 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants, issued February 1997.
6. Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components, issued May 1995.
7. Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Guidance for Industry and Food and Drug Administration Staff, issued April 2019.
8. Reporting of Computational Modeling Studies in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff, issued September 2016.
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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