| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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11-303
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| Standard | |
ASTM F3047M-15
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 of what high demand test features may need to be added to an overall high demand wear test regime. Device articulating components manufactured from other metallic alloys, ceramics or with coated or elementally modified surfaces could possibly be evaluated with this guide. However such materials may include risks and failure mechanisms which are not adressed in this guide.
1.2 Hard-on-hard hip bearing systems include metal-on-metal, ceramic-on-ceramic, 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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Relevant FDA Guidance and/or Supportive Publications*
| 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. |
