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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 11-387
Standard
ASTM  F1781-21
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Scope/Abstract
1.1 This specification covers elastomeric flexible hinge finger total joint implants, used with and without metal grommets, in the reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints.

1.2 This specification excludes those implants that do not have an across-the-joint elastomeric linkage. This specification is limited to implants made from one material in a single, one-step molding procedure.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3230 Prosthesis, Finger, Polymer Class 2 KWF
§888.3230 Prosthesis, Finger, Constrained, Polymer Class 2 KYJ
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
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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