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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 061 Date of Entry 12/18/2023 
FR Recognition Number 11-402
Standard
ASTM  F1798-21
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
Scope/Abstract
1.1 This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants.

1.2 The purpose of this test method is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this test method to address the analysis of spinal implant constructs or subconstructs or to define levels of performance of spinal implants, as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs.

1.3 This standard defines test methods to measure the strength of spinal implant component interconnections and how to report test results.
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FDA recognition of ASTM F1798-13 [Rec# 11-276] will be superseded by recognition of ASTM F1798-21 [Rec# 11-402]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-276] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 11-276] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3050 Appliance, Fixation, Spinal Interlaminal Class 2 KWP
§888.3060 Appliance, Fixation, Spinal Intervertebral Body Class 2 KWQ
§888.3070 Thoracolumbosacral Pedicle Screw System Class 2 NKB
§888.3070 Posterior Metal/Polymer Spinal System, Fusion Class 2 NQP
§888.3070 Growing Rod System Class 2 PGM
§888.3070 Growing Rod System- Magnetic Actuation Class 2 PGN
§888.3075 Posterior Cervical Screw System Class 2 NKG
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Spinal System 510(k)s, issued May 2004.

Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, issued January 2000.

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/
  301-796-5650
  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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