Recognized standard
F3161-16
FDA recognition 11-308 · ASTM · Orthopedic
Key facts
| Recognition number | 11-308 |
|---|---|
| Designation | F3161-16 |
| Title | Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jun 27, 2016 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This standard establishes requirements and considerations for the numerical simulation of metallic orthopaedic cemented and cementless total knee femoral components using Finite Element Analysis (FEA) techniques for the estimation of stresses and strains. This standard is only applicable to… |
At a glance
- 10–99 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: