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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 057 Date of Entry 12/20/2021 
FR Recognition Number 11-388
Standard
ASTM  F1717-21
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Scope/Abstract
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine.

1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and 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 one fatigue test are defined for the comparative evaluation of spinal implant assemblies.

1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.

1.5 Some spinal constructs 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
§888.3050 Appliance, Fixation, Spinal Interlaminal Class 2 KWP
§888.3060 Appliance, Fixation, Spinal Intervertebral Body Class 2 KWQ
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Thoracolumbosacral Pedicle Screw System Class 2 NKB
§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.

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.
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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