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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 047 Date of Entry 08/21/2017 
FR Recognition Number 11-280
ASTM  F2624-12 (Reapproved 2020)
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
1.1 This test method describes methods to assess the static and dynamic properties of single level spinal constructs.

1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein, is used for the analysis of devices intended for motion preservation, using testing medium as defined in this standard (6.1).

1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony interfaces.

1.4 It is the intent of this test method to enable single level extra-discal spinal constructs with regard to kinematic, functional, and wear characteristics when tested under the specified conditions.

1.5 This test method is not intended to address facet arthroplasty devices.

1.6 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures be established. This test method is intended to facilitate uniform testing methods and data reporting.

1.7 The motion profiles specified by this test method do not necessarily accurately reproduce those occurring in vivo. Rather this method provides useful boundary/endpoint conditions for evaluating implant designs in a functional manner.

1.8 This test method is not intended to be a performance standard. It is the responsibility of the user of this test method to characterize the safety and effectiveness of the device under evaluation.

1.9 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required.
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
§888.3050 Spinous Process Plate Class 2 PEK
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Spinal System 510(k)s, May 3, 2004

Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 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
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.