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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Recognition 04/04/2016 
FR Recognition Number 11-228
Standard
ASTM F564-10 (Reapproved 2015)
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 muscular skeletal 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.
Transition Period
FDA recognition of ASTM F564-10 [Rec# 11-228] will be superseded by recognition of ASTM F564-17 [Rec# 11-325]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-228] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 11-228] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§888.3040 Pin, Fixation, Smooth Class 2 HTY
§888.3040 Pin, Fixation, Threaded Class 2 JDW
§888.3030 Plate, Fixation, Bone Class 2 HRS
§888.3030 Staple, Fixation, Bone Class 2 JDR
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Jonathan Peck
  FDA/OMPT/CDRH/ODE/DOD/PSDB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
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