| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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066
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Date of Entry 05/25/2026
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FR Recognition Number
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11-445
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| Standard | |
ASTM F2009-25
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
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Scope/Abstract1.1 This test method establishes a standard methodology for determining the force required, under laboratory conditions, to disassemble tapers of implants that are otherwise not intended to release. Some examples are the femoral components of a total or partial hip joint replacement or humeral components of an anatomic total or partial shoulder joint replacement in which the head and base component are secured together by a self-locking taper.
1.2 In this test method, it is recognized that actual loading during surgery and in vivo is quite varied, and that no one set of experimental conditions can encompass all possible variations. Thus, the test method included here represents a simplified model for purposes of comparison between designs and materials. Test methods involving more complex systems may require additional justification.
1.3 This test method has been developed primarily for evaluation of metal and ceramic head designs on metal tapers but can have application to other materials and designs. |
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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| FDA recognition of ASTM F2009-20 [Rec# 11-371] will be superseded by recognition of ASTM F2009-25 [Rec# 11-445]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-371] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 11-371] 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
|
Class 3
|
KXD
|
| §888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
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Class 2
|
KWZ
|
| §888.3320 |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
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Class 3
|
JDL
|
| §888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
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Class 3
|
KWA
|
| §888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal
|
Class 2
|
KMC
|
| §888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
Class 2
|
JDI
|
| §888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
|
Class 2
|
OQH
|
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
Class 2
|
LZO
|
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
|
Class 2
|
MAY
|
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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Class 2
|
MEH
|
| §888.3353 |
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
|
Class 2
|
OQI
|
| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
Class 2
|
LPH
|
| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
|
Class 2
|
MBL
|
| §888.3358 |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
|
Class 2
|
OQG
|
| §888.3360 |
Prosthesis, Upper Femoral
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Class 2
|
JDD
|
| §888.3360 |
Prosthesis, Hip, Femoral Component, Cemented, Metal
|
Class 2
|
JDG
|
| §888.3360 |
Prosthesis, Hip, Hemi-, Femoral, Metal
|
Class 2
|
KWL
|
| §888.3360 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
|
Class 2
|
LWJ
|
| §888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
|
Class 2
|
KWY
|
| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented |
Class 3
|
LPF
|
| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3
|
MRA
|
|
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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