Recognized standard
F2979-20
FDA recognition 11-380 · ASTM · Orthopedic
Key facts
| Recognition number | 11-380 |
|---|---|
| Designation | F2979-20 |
| Title | Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This standard guide provides options and a compendium of information for measuring the bearing surface and estimating the in-vivo wear of explanted Metal-on-Metal (MoM) and other "hard" (for example, ceramic) hip components. The guide covers the measurement of acetabular cups and femoral heads… |
At a glance
- 1–9 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: