Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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040
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Date of Entry 08/14/2015
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FR Recognition Number
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11-294
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Standard | |
ASTM F1357 -14 (Reapproved 2019) Standard Specification for Articulating Total Wrist Implants |
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Scope/Abstract1.1 This specification describes total wrist implants, including solid ceramic 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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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3800 |
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained |
Class 2 |
JWI |
§888.3800 |
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained |
Class 2 |
JWJ |
§888.3800 |
Prosthesis, Wrist, Semi-Constrained |
Class 2 |
KWM |
§888.3790 |
Prosthesis, Wrist, Constrained, Metal |
Class 3 |
KYN |
§888.3780 |
Prosthesis, Wrist, Constrained, Polymer |
Class 2 |
KIG |
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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. |