Recognized standard
F3129-24
FDA recognition 11-412 · ASTM · Orthopedic
Key facts
| Recognition number | 11-412 |
|---|---|
| Designation | F3129-24 |
| Title | Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 23, 2024 |
| Scope (excerpt) | 1.1 This guide specifies a method to measure the surface features, such as hills and valleys, and to estimate the in vivo material loss from the conical taper junctions, such as the femoral head/stem junction or adapter sleeve from explanted modular hip prosthesis, modular knee, or shoulder joints… |
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: