Recognized standard
F3738-25
FDA recognition 11-440 · ASTM · Orthopedic
Key facts
| Recognition number | 11-440 |
|---|---|
| Designation | F3738-25 |
| Title | Standard Test Method for Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This test method describes a laboratory method for evaluating the wear performance of metal-on-polyethylene hip joint prostheses under adverse conditions using third-body particles (simulated Mode 3 wear conditions).2 Procedures for particle selection and preparation, test setup, particle… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: