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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 050 Date of Entry 09/17/2018 
FR Recognition Number 11-325
Standard
ASTM  F564-17
Standard Specification and Test Methods for Metallic Bone Staples
Scope/Abstract
1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the musculoskeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples.
1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:
1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples-Annex A1.
1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples-Annex A2.
1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples-Annex A3.
1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples-Annex A4.
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
§888.3030 Plate, Fixation, Bone Class 2 HRS
§888.3030 Staple, Fixation, Bone Class 2 JDR
§888.3040 Pin, Fixation, Smooth Class 2 HTY
§888.3040 Pin, Fixation, Threaded Class 2 JDW
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
 Christopher Ferreira
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/
  301-796-9350
  christopher.ferreira@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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