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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 063 Date of Entry 12/23/2024 
FR Recognition Number 11-411
Standard
ASTM  F1611-20 (Reapproved 2024)
Standard Specification for Intramedullary Reamers
Scope/Abstract
1.1 This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone.

1.2 Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFDs). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered.
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.
Transition Period
FDA recognition of ASTM F1611-00 (Reapproved 2018) [Rec# 11-310] will be superseded by recognition of ASTM F1611-20 (Reapproved 2024) [Rec# 11-411]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-310] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 11-310] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3020 Rod, Fixation, Intramedullary And Accessories Class 2 HSB
§888.4540 Reamer Class 1 HTO
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 Contacts
 Jonathan Peck
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
 Mahlet Zinah
  FDA/CDRH/OPEQ/OHTVI/DHTVIC
  240-402-2623
  Mahlet.Zinah@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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