Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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11-362
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Standard | |
ISO 22622 First edition 2019-07 Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test |
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Scope/AbstractThis document specifies the relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total ankle-joint prostheses in wear-testing machines with load or displacement control. NOTE This document is based on the method described by ISO 14243-1 and ISO 14243-3 and allows for the use of the same test equipment as for total knee replacement wear testing. |
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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 |
§888.3100 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite
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Class 2
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KMD
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§888.3110 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
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Class 2
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HSN
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§888.3120 |
Prosthesis, Ankle, Cemented, Non-Constrained
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Class 3
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KXC
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N/A |
Prosthesis, Ankle, Uncemented, Non-Constrained |
Class 3
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NTG
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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. |