Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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11-333
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Standard | |
ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates |
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Scope/Abstract1.1 This specification and test method is intended to provide a comprehensive reference for metallic bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates. 1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Furthermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system. 1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application. 1.4 This document includes the following test methods used in determining the following bone plate mechanical performance characteristics: 1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates-Annex A1, and 1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates-Annex A2.
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Extent of Recognition
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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. |
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Transition Period
FDA recognition of ASTM F382-17 [Rec# 11-333] will be superseded by recognition of ASTM F382-24 [Rec# 11-414]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-333] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 11-333] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3030 |
Plate, Fixation, Bone
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Class 2
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HRS
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§888.3030 |
Condylar Plate Fixation Implant
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Class 2
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JDP
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§888.3030 |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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Class 2
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KTT
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§888.3030 |
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
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Class 2
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KTW
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§888.3030 |
Appliance, Nail/Blade/Plate Combination, Single Component
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Class 2
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KWK
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§888.3030 |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
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Class 2
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LXT
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§888.4540 |
Instrument, Bending Or Contouring
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Class 1
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HXP
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§888.4540 |
Bender
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Class 1
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HXW
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |