| Part B: Supplementary Information Sheet (SIS) |
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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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11-326
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| Standard | |
ASTM F384-17
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices |
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Scope/Abstract1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This 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 angled devices.
1.2 It is not the intention of this standard to define levels of performance or case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, this standard does not describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system.
1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application.
NOTE 1-This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate.
1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics:
1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1).
1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see 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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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.3020 |
Rod, Fixation, Intramedullary And Accessories
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Class 2
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HSB
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| §888.3030 |
Device, Fixation, Proximal Femoral, Implant
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Class 2
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JDO
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| §888.3030 |
Nail, Fixation, Bone
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Class 2
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JDS
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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, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
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Class 2
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LXT
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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. |
