• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 11-310
ASTM  F1611-00 (Reapproved 2018)
Standard Specification for Intramedullary Reamers
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 (IMFD). 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.
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*
Reviewers Guidance Checklist For Intramedullary Rods version #4, Issued February 1997.

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
 Christopher Ferreira
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.