| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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11-368
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| Standard | |
ASTM F3334-19
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components |
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Scope/Abstract1.1 This practice establishes requirements and considerations for the numerical simulation of metallic orthopaedic total knee tibial components using Finite Element Analysis (FEA) techniques for the estimation of stresses and strains. This practice is only applicable to stresses below the yield strength, as provided in the material certification.
1.2 Purpose-This practice establishes requirements and considerations for the development of finite element models to be used in the evaluation of metallic orthopaedic total knee tibial component designs for the purpose of prediction of the static implant stresses and strains. This procedure can be used for worst-case assessment within a series of different implant s of the same implant design to reduce the physical test burden. Recommended procedures for performing model checks and verification are provided as an aid to 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 practice is limited in discussion to the static structural analysis of metallic orthopaedic total knee tibial components (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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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.3480 |
Metal Cemented Constrained Femorotibial Knee Prosthesis
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Class 3
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KRN
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| §888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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Class 2
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HSX
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| §888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
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Class 2
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HRY
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| §888.3550 |
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
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Class 3
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KRP
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| §888.3550 |
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
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Class 2
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KRQ
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| §888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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Class 2
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JWH
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| §888.3560 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
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Class 2
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MBV
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| §888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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Class 2
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OIY
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| §888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
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Class 2
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MBH
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| N/A |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer |
Class 3
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LXY
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| N/A |
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 3
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MBD
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| N/A |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing |
Class 3
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NJL
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA: Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses, Issued January 2003.
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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