Recognized standard
7207-2 Third edition 2025-08
FDA recognition 11-436 · ISO · Orthopedic
Key facts
| Recognition number | 11-436 |
|---|---|
| Designation | 7207-2 Third edition 2025-08 |
| Title | Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This document specifies surface finish requirements for the articulating surfaces of total and partial knee joint prostheses classified in ISO 7207-1. This document is intended to provide guidance for periodic validation of production processes. |
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: