| ISO 5838-2 First edition 1991-01-15 Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 11-74 |
| 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 the dimensions of Steinmann skeletal pins. Material and mechanical requirements are covered by ISO 5838-1.
NOTE 1 Attention is drawn to the possible need for different designs of points depending on such factors as the method of insertion, and the site of insertion, i.e. whether the bone is cancellous or cortical.
| 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 Orthopedics External Fixation Devices, 2/21/97 |