ASTM F384-24
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

Standard No.

ASTM F384-24

Release Date

2024

Published By

American Society for Testing and Materials (ASTM)

Lastest

ASTM F384-24

Scope

1.1 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.

ASTM F384-24 Referenced Document

• ASTM E122 Standard Practice for Calculating Sample Size to Estimate, With a Specified Tolerable Error, the Average for Characteristic of a Lot or Process
• ASTM E4 Standard Practices for Force Verification of Testing Machines
• ASTM E8/E8M Standard Test Methods for Tension Testing of Metallic Materials
• ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
• ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• ASTM F382 Standard Specification and Test Method for Metallic Bone Plates
• ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• ASTM F620 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• ASTM F621 Standard Specification for Stainless Steel Forgings for Surgical Implants
• ASTM F983 Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ISO 14602 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
• ISO 5835 Implants for surgery; metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread; dimensions
• ISO 5836 Implants for surgery; metal bone plates; holes corresponding to screws with asymmetrical thread and spherical under-surface
• ISO 9268 Implants for surgery; metal bone screws with conical under-surface of head; dimensions
• ISO 9269 Implants for surgery; metal bone plates; holes and slots corresponding to screws with conical under-surface

ASTM F384-24 history

• 2024 ASTM F384-24 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2017 ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2012 ASTM F384-12 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2006 ASTM F384-06(2011) Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2006 ASTM F384-06e1 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2006 ASTM F384-06 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• 2000 ASTM F384-00 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices