| ASTM F366-10 (Reapproved 2015) Standard Specification for Fixation Pins and Wires |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 11-227 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
| FDA Tech | Jonathan Peck FDA/OMPT/CDRH/ODE/DOD/PSDB/ 301-796-5650 jonathan.peck@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
1.1 This specification covers functional dimensions for fixation pins and wires.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3040 | Pin, Fixation, Smooth | Class 2 | HTY |
| §888.3040 | Pin, Fixation, Threaded | Class 2 | JDW |
| §888.3030 | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class 2 | KTT |
| Reviewers Guidance Checklist for Orthopedic External Fixation Devices Version #5, 2/21/97 |