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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 051 Date of Entry 01/14/2019 
FR Recognition Number 11-347
Standard
ASTM  F2077-18
Test Methods for Intervertebral Body Fusion Devices
Scope/Abstract
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.

1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.

1.3 The test method describes 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 intervertebral body fusion device assemblies.

1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.

1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).

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

1.7 Some intervertebral body 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
§888.3060 Spinal Vertebral Body Replacement Device Class 2 MQP
§888.3080 Intervertebral body fusion device; Intervertebral Fusion Device With Bone Graft, Lumbar Class 2 MAX
§888.3080 Intervertebral body fusion device; Intervertebral Fusion Device With Bone Graft, Cervical Class 2 ODP
§888.3080 Intervertebral body fusion device; Intervertebral Fusion Device With Integrated Fixation, Lumbar Class 2 OVD
§888.3080 Intervertebral body fusion device; Intervertebral Fusion Device With Integrated Fixation, Cervical Class 2 OVE
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

Guidance for Industry and FDA Staff: Spinal System 510(k)s, Issued May 2004

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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