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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 049 Date of Entry 06/07/2018 
FR Recognition Number 15-54
ASTM  F3207-17
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
1.1 Historically, the single-level rabbit posterolateral, or intertransverse, lumbar spine fusion model was developed and reported on by Dr. Scott Boden, et. al. (Emory Spine Center for Orthopedics) and the model has been proposed as a nonclinical model which may be used to replicate clinically relevant fusion rates for iliac crest autograft in the posterolateral spine (1, 2).2 This model is used routinely in submissions to regulatory bodies for the purpose of evaluating the potential efficacy of bone void filler materials as compared to other materials or iliac crest autograft to effect spinal posterolateral fusion. The use of this standards recommendations as part of a regulatory submission does not provide any guarantee of regulatory clearance and should be considered as a part of the data provided for regulatory submission.
1.2 This guide covers general guidelines to evaluate the effectiveness of products intended to cause and/or promote bone formation in the lumbar intertransverse process spinal fusion model in vivo. This guide is applicable to products that may be composed of one or more of the following components: natural biomaterials (such as demineralized bone), and synthetic biomaterials (such as calcium sulfate, glycerol, and reverse phase polymeric compounds) that act as additives, fillers, and/or excipients (radioprotective agents, preservatives, and/or handling agents). It should not be assumed that products evaluated favorably using this guidance will form bone when used in a clinical setting. The primary purpose of this guide is to facilitate the equitable comparison of bone void fillers and/or autograft extender products in vivo. The purpose of this guide is not to exclude other established methods.
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
§888.3045 Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Class 2 MBP
§888.3045 Filler, Bone Void, Calcium Compound Class 2 MQV
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device, Issued June 2003

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
 Aric Kaiser
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Groups (STG)
Tissue Engineering (primary)
*These are provided as examples and others may be applicable.