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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 059 Date of Entry 12/19/2022 
FR Recognition Number 11-398
Standard
ASTM  F3574-22
Standard Test Methods for Sacroiliac Joint Fusion Devices
Scope/Abstract
1.1 These test methods cover the materials and methods for the static and dynamic testing of sacroiliac joint (SIJ) fusion device assemblies, SIJ implants designed to promote arthrodesis at the sacroiliac joint.

1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic SIJ fusion device assemblies. These test methods allow for comparison of SIJ fusion device assemblies intended to be implanted with a trajectory in line with the joint space (in-line implant) or for comparison of SIJ fusion devices intended for implantation across the joint space (transverse implant). These test methods are intended enable the user to compare SIJ fusion device assemblies mechanically and do not purport to provide performance standards for SIJ fusion device assemblies.

1.3 These tests describe static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of SIJ device assemblies.

1.4 Guidelines are established for measuring displacements, determining the yield force or moment, and evaluating the stiffness and strength of the SIJ fusion device assemblies.

1.5 Some SIJ fusion device assemblies may not be testable in all test configurations.
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
§888.3040 Sacroiliac Joint Fixation Class 2 OUR
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
 Jonathan Peck
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-6429
  jonathan.peck@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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