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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Recognition 04/04/2016 
FR Recognition Number 11-296
Standard
ASTM F2193-14
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
Scope/Abstract
1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used to describe the and other physical characteristics of spinal components and performance definitions related to the performance of spinal components. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components.

1.2 These specifications and test methods are part of a series of standards addressing systems used in the surgical fixation of the spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found in many spinal fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, the interconnections between individual components and subassemblies (two or more components), the user should consult Guide F1798. At the highest level in this chain is Test Methods F1717, which is used to evaluate an entire construct assembled from many components and involves numerous interconnections and several subassemblies.

1.3 It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components addressed by this document. Insufficient knowledge to predict the consequences of using any of these components in individual patients for specific activities of daily living is available. Furthermore, it is not the intention of this document to describe or specify specific designs for the individual components of systems used in the surgical internal fixation of the spinal skeletal system.

1.4 These specifications and test methods may not be appropriate for all types of spinal surgical fixation systems. The user is cautioned to consider the appropriateness of this document in view of the particular implant system and its potential application.

1.5 This document includes the following specifications and test methods that are used in determining the spinal component's mechanical performance characteristics:

1.5.1 Specification for Metallic Spinal Screws-Annex A1.

1.5.2 Specification for Metallic Spinal Plates-Annex A2.

1.5.3 Specification for Metallic Spinal Rods-Annex A3.

1.5.4 Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal Screws-Annex A4.

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.
Transition Period
FDA recognition of ASTM F2193-14 [Rec# 11-296] will be superseded by recognition of ASTM F2193-18 [Rec# 11-332]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-296] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 11-296] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
§888.3070 Thoracolumbosacral Pedicle Screw System Class 2 NKB
§888.3060 Appliance, Fixation, Spinal Intervertebral Body Class 2 KWQ
§888.3050 Appliance, Fixation, Spinal Interlaminal Class 2 KWP
§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, May 3, 2004

Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 2000
FDA Technical Contact
 Jonathan Peck
  FDA/OMPT/CDRH/ODE/DOD/PSDB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
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