| 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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11-407
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| Standard | |
ASTM F3140-23
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements |
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Scope/Abstract1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements.
1.2 This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover either the medial or the lateral plateau of the tibia.
1.3 This test method may require modifications to accommodate other tibial tray designs.
1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported mid-section of the condyle. |
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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| FDA recognition of ASTM F3140-17 [Rec# 11-341] will be superseded by recognition of ASTM F3140-23 [Rec# 11-407]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-341] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 11-341] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
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Class 2
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NJD
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| N/A |
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
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Class 3
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NRA
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Relevant FDA Guidance and/or Supportive Publications*
1. Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 2003.
2. Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, issued April 1994.
3. 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.
4. Guidance Document - 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants, issued February 1997.
5. Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components, issued May 1995.
6. Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Guidance for Industry and Food and Drug Administration Staff, issued April 2019.
7. 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. |
