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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 11-346
ASTM F2706-18
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
1.1 These test methods cover the materials and methods for the static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of occipital-cervical and occipital-cervical-thoracic spinal implant components can be specific depending on the intended location and intended method of attachment.

1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. They allow comparison of occipital-cervical and occipital-cervical-thoracic spinal implant constructs with different methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.

1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and two fatigue tests for the comparative evaluation of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are defined.

1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of occipital-cervical or occipital-cervical-thoracic spinal implant assemblies.

1.5 It may not be possible to test some occipital-cervical and some occipital-cervical-thoracic spinal constructs 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
§888.3050 Appliance, Fixation, Spinal Interlaminal Class 2 KWP
Orthosis, Cervical Pedicle Screw Spinal Fixation
§888.3075 Posterior Cervical Screw System Class 2 NKG
Relevant FDA Guidance and/or Supportive Publications*
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
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.