| ASTM F1541-02 (Reapproved 2015) Standard Specification and Test Methods for External Skeletal Fixation Devices |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 11-203 |
| 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 provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate goal is to develop a specification, which defines performance criteria and methods for measurement of performance-related mechanical characteristics of ESFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of the devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. Furthermore, it is not the intention of this specification to describe or specify specific designs for ESFDs.
1.2 This specification describes ESFDs for surgical fixation of the skeletal system. It provides basic ESFD geometrical definitions, dimensions, classification, and terminology; material specifications; performance definitions; test methods; and characteristics determined to be important to the in-vivo performance of the device.
1.3 This specification includes a terminology and classification annex and five standard test method annexes as follows:
1.3.1 Classification of External Fixators-Annex A1.
1.3.2 Test Method for External Skeletal Fixator Connectors-Annex A2.
1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements-Annex A3.
1.3.4 Test Method for External Skeletal Fixator Joints-Annex A4.
1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements-Annex A5.
1.3.6 Test Method for External Skeletal Fixator Subassemblies-Annex A6.
1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies-Annex A7.
1.4 A rationale is given in Appendix X1.
| 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 |