Recognized standard
F2009-20
FDA recognition 11-371 · ASTM · Orthopedic
Key facts
| Recognition number | 11-371 |
|---|---|
| Designation | F2009-20 |
| Title | Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This test method establishes a standard methodology for determining the force required, under laboratory conditions, to disassemble tapers of implants that are otherwise not intended to release. Some examples are the femoral components of a total or partial hip replacement or shoulder in which… |
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: