Recognized standard

F3090-24

FDA recognition 11-417 · ASTM · Orthopedic

Key facts

Recognition number 11-417
Designation F3090-24
Title Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements
Standards developer ASTM International
Specialty area Orthopedic
Date of entry Dec 23, 2024
Device classes Class 3, Class 2
Scope (excerpt) 1.1 This test method is intended to evaluate the fatigue strength and performance of metallic acetabular shells with hemispheric outer surfaces. 1.2 This test method, as described, is not intended to evaluate the following: the strength of components that may be mated with the acetabular shells (for…

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