| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
060
|
Date of Entry 05/29/2023
|
|
FR Recognition Number
|
11-399
|
| Standard | |
ASTM F1357-23
Standard Specification for Articulating Total Wrist Implants |
|
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. |
|
| 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 |
| §888.3780 |
Prosthesis, Wrist, Constrained, Polymer
|
Class 2
|
KIG
|
| §888.3790 |
Prosthesis, Wrist, Constrained, Metal
|
Class 3
|
KYN
|
| §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
|
|
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. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
