| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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059
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Date of Entry 12/19/2022
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FR Recognition Number
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11-397
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| Standard | |
ASTM F3210-22e1
Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions |
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Scope/Abstract1.1 This standard applies to metallic total knee femoral components used in total knee arthroplasty (TKA). Femoral components made of nonmetallic materials (for example, ceramic, polymer) could possibly be evaluated using this test method. However, such materials may include risks of new failure mechanisms which are not considered in this test method.
1.2 The procedure described in this standard is performed on total knee femoral components for supporting determination of fatigue behavior under closing-style loading conditions. Closing-style loading refers to forces that act to reduce the femoral intercondylar depth, resulting in a tensile stress on the articular surface of the femoral condyle. (See 3.2.2.)
1.3 Different designs can be characterized as, but not limited to, posterior cruciate ligament retaining (CR), posterior stabilizing (PS), and revision.
1.4 This standard does not address evaluation of femoral components under opening-style loading conditions which have also generated clinical failures. Under opening-style loading conditions, forces are applied to the inner contour of the femoral component in a way that the forces act to increase the intercondylar depth, or open the femoral component. |
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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 |
| §888.3490 |
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
|
Class 2
|
KMB
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| §888.3490 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
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Class 2
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KTX
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| §888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
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Class 2
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KYK
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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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| §888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
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Class 2
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LGE
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| §888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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Class 2
|
JWH
|
| §888.3560 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
|
Class 2
|
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
|
| N/A |
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 3
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MBD
|
| N/A |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing |
Class 3
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NJL
|
|
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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