| 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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11-440
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| Standard | |
ASTM F3738-25
Standard Test Method for Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles |
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Scope/Abstract1.1 This test method describes a laboratory method for evaluating the wear performance of metal-on-polyethylene hip joint prostheses under adverse conditions using third-body particles (simulated Mode 3 wear conditions).2 Procedures for particle selection and preparation, test setup, particle embedding, wear testing, and reporting requirements are described. Dual-mobility total hip replacements and characterization of femoral heads are outside of the scope of this standard test method.
1.2 This test method aims to provide an understanding of performance between differing implant designs and materials under the controlled introduction of reproducible and well-characterized third-body particles. While this method creates testing conditions and component damage more severe than that typically observed clinically, it is intended to provide a uniform methodology for evaluating relative differences in in vitro Mode 3 wear performance.
1.3 The intent of this test method is to quantitatively and qualitatively rank the materials and designs of polyethylene liners in metal-on-polyethylene bearing couples by evaluating mass change, wear mechanisms, and resulting damage arising from simulated Mode 3 wear conditions. The quantitative methods recommended herein may be used with consideration of the limitations arising from this test method. See Appendix X1 for further details on the rationale for including quantitative methods in addition to qualitative data. |
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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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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
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Class 2
|
KWZ
|
| §888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
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Class 2
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PBI
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| §888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal
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Class 2
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KMC
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| §888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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Class 2
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JDI
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| §888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
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Class 2
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OQH
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| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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Class 2
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LZO
|
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
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Class 2
|
MAY
|
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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Class 2
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MEH
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| §888.3353 |
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
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Class 2
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OQI
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| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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Class 2
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LPH
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| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
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Class 2
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MBL
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| §888.3358 |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
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Class 2
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OQG
|
| §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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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. |
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