| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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FR Recognition Number
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11-423
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| Standard | |
ASTM F2267-24
Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
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Scope/Abstract1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, 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 non-biologic intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.
1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test method is designed to allow for the comparative evaluation of intervertebral body fusion devices.
1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices.
1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage. |
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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| FDA recognition of ASTM F2267-04 (Reapproved 2018) [Rec# 11-185] will be superseded by recognition of ASTM F2267-24 [Rec# 11-423]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-185] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 11-185] 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
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Class 2
|
MQP
|
| §888.3060 |
Spinal Vertebral Body Replacement Device - Cervical
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Class 2
|
PLR
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| §888.3080 |
Intervertebral Fusion Device With Bone Graft, Lumbar
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Class 2
|
MAX
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| §888.3080 |
Intervertebral Fusion Device With Bone Graft, Cervical
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Class 2
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ODP
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| §888.3080 |
Intervertebral Fusion Device With Integrated Fixation, Lumbar
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Class 2
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OVD
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| §888.3080 |
Intervertebral Fusion Device With Integrated Fixation, Cervical
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Class 2
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OVE
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| §888.3080 |
Intervertebral Fusion Device With Bone Graft, Thoracic
|
Class 2
|
PHM
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| N/A |
Prosthesis, Intervertebral Disc |
Class 3
|
MJO
|
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs, issued April 2008.
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.
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. |
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| 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. |
