Recognized standard
F2996-20
FDA recognition 11-372 · ASTM · Orthopedic
Key facts
| Recognition number | 11-372 |
|---|---|
| Designation | F2996-20 |
| Title | Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This practice establishes requirements and considerations for the numerical simulation of non-modular (that is, limited to monolithic stems with only a femoral head/trunnion taper interface) metallic orthopaedic hip stems using Finite Element Analysis (FEA) techniques for the estimation of… |
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: