| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
|
040
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Date of Entry 08/14/2015
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|
FR Recognition Number
|
11-294
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| Standard | |
ASTM F1357 -14 (Reapproved 2019)
Standard Specification for Articulating Total Wrist Implants |
|
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
|
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 |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
