| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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|
FR Recognition Number
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11-421
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| Standard | |
ASTM F2077-24
Standard Test Methods for Intervertebral Body Fusion Devices |
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Scope/Abstract1.1 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, and 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. |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ASTM F2077-18 [Rec# 11-347] will be superseded by recognition of ASTM F2077-24 [Rec# 11-421]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-347] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 11-347] will not be accepted. |
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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
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Class 2
|
MAX
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|
§888.3080
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Intervertebral body fusion device; Intervertebral Fusion Device With Bone Graft, Cervical
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Class 2
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ODP
|
|
§888.3080
|
Intervertebral body fusion device; Intervertebral Fusion Device With Integrated Fixation, Lumbar
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Class 2
|
OVD
|
|
§888.3080
|
Intervertebral body fusion device; Intervertebral Fusion Device With Integrated Fixation, Cervical
|
Class 2
|
OVE
|
|
§888.3080
|
Intervertebral body fusion device; 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.
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
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
