| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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FR Recognition Number
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11-439
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| Standard | |
ASTM F3437-23
Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation |
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Scope/Abstract1.1 This standard is intended to provide guidance for the static testing of small bone metallic plates used for fracture fixation. Small bone plates referred to in this standard would be used in minimally load-bearing anatomical areas of the far extremities, such as the fingers and toes, and in the cranium and upper face. Lower face/mandible, wrist, and ankle fixation plates would generally be larger and carry a substantial amount of load and should not be evaluated under this standard.
1.2 ASTM Specification F382 and ISO 9585 are currently available for the testing of metallic bone plates as well, so the user can choose to use any of the tests in these standards for small bone plates. However, due to plate size, Specification F382 and ISO 9585 test setup and execution difficulty can be increased for small bone plates. Thus, this standard offers alternative test methods that are more appropriate for metallic bone plates used in small bone fracture fixation.
1.3 This standard is not intended to address the mechanical performance of the plating construct or accessory components (for example, screws and wires).
1.4 This standard is intended to provide a basis for the mechanical comparison of small bone plates. Due to the complex and varying biomechanics found in the areas of the body where these plates are used, this standard should only be used to compare the in vitro mechanical performance of small bone plates and not used to infer in vivo performance characteristics.
1.5 This standard describes static tests by specifying load types and specific methods of applying these loads. Tests for evaluating and characterizing these loads include the following: static torsion, static cantilever beam bending, static lateral bending, and static three-point bending. |
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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 |
| §888.3030 |
Plate, Fixation, Bone
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Class 2
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HRS
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Relevant FDA Guidance and/or Supportive Publications*
Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff, issued November 2024.
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. |
