Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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11-399
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Standard | |
ASTM F1357-23 Standard Specification for Articulating Total Wrist Implants |
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Scope/Abstract1.1 This specification describes total wrist implants used to provide functioning articulation by employing radial and carpal components.
1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one-piece elastomeric implants (with or without grommets), and those devices used for custom applications. |
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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FDA recognition of ASTM F1357 -14 (Reapproved 2019) [Rec# 11-294] will be superseded by recognition of ASTM F1357 - 23 [Rec# 11-399]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-294] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 11-294] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3780 |
Prosthesis, Wrist, Constrained, Polymer
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Class 2
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KIG
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§888.3790 |
Prosthesis, Wrist, Constrained, Metal
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Class 3
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KYN
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§888.3800 |
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
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Class 2
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JWI
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§888.3800 |
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
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Class 2
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JWJ
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§888.3800 |
Prosthesis, Wrist, Semi-Constrained
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Class 2
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KWM
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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. |