| ISO 5838-1 Third edition 2013-03-01 Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 11-252 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.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.
This part of ISO 5838 specifies general requirements for metallic skeletal pins and wires for use in bone surgery, excluding wires for binding and twisting.
| 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, 2/21/97 |