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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 063 Date of Entry 12/23/2024 
FR Recognition Number 11-418
Standard
ASTM  F3631-24
Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
Scope/Abstract
1.1 This test method covers the materials and methods for impact testing of lumbar intervertebral body fusion devices (IBFD).

1.2 This test method is intended to provide a basis for the mechanical comparison among nonbiologic IBFD assemblies (the IBFD and associated inserter tool). This test method is intended to enable the user to compare these IBFD assemblies under impact loads to simulate the intra-operative surgical technique used to insert the IBFD.

1.3 The test method describes the impact test by specifying impact energies and specific methods for applying these energies. The tests are designed to allow for the comparative evaluation of IBFD assemblies.
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
§888.3080 Intervertebral Fusion Device With Bone Graft, Lumbar Class 2 MAX
§888.3080 Intervertebral Fusion Device With Bone Graft, Cervical Class 2 ODP
§888.3080 Intervertebral Fusion Device With Integrated Fixation, Lumbar Class 2 OVD
§888.3080 Intervertebral Fusion Device With Integrated Fixation, Cervical Class 2 OVE
§888.3080 Intervertebral Fusion Device With Bone Graft, Thoracic Class 2 PHM
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, issued June 2007.

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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