Recognized standard
14879-1 Second edition 2020-07
FDA recognition 11-370 · ISO · Orthopedic
Key facts
| Recognition number | 11-370 |
|---|---|
| Designation | 14879-1 Second edition 2020-07 |
| Title | Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This document specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastic articulating surface. It applies to tibial trays which cover both the medial and lateral plateaux 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: