Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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11-416
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Standard | |
ASTM F2996-24 Standard Test Method for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
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Scope/Abstract1.1 This standard establishes requirements and considerations for the numerical simulation of non-modular (that is, limited to monolithic stems with only a femoral head/trunnion taper interface) metallic orthopaedic hip stems using Finite Element Analysis (FEA) techniques for the estimation of stresses and strains. This standard is only applicable to stresses below the yield strength, as provided in the material certification.
1.2 Purpose-This test method establishes requirements and considerations for the development of finite element models to be used in the evaluation of non-modular metallic orthopaedic hip stem designs for the purpose of prediction of the static implant stresses and strains. The context of use is to apply the finite element method to identify the worst-case size within a series of different sizes of the same implant design and to subsequently test that worst-case size (as is typically required). Recommended procedures for performing model checks and verification are provided to help determine if the analysis follows recommended guidelines. Finally, the recommended content of an engineering report covering the mechanical simulation is presented.
1.3 Limits-This test method is limited in discussion to the static structural analysis of non-modular metallic orthopaedic hip stems (which excludes the prediction of fatigue strength).
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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FDA recognition of ASTM F2996-20 [Rec# 11-372] will be superseded by recognition of ASTM F2996-24 [Rec# 11-416]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-372] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 11-372] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
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Class 2
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KWZ
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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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§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
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§888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
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Class 2
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MAY
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§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
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§888.3360 |
Prosthesis, Upper Femoral
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Class 2
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JDD
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§888.3360 |
Prosthesis, Hip, Femoral Component, Cemented, Metal
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Class 2
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JDG
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§888.3360 |
Prosthesis, Hip, Hemi-, Femoral, Metal
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Class 2
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KWL
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§888.3360 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
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Class 2
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LWJ
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§888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
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Class 2
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KWY
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N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented |
Class 3
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LPF
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N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3
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MRA
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses, issued September 2007.
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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