| ASTM F382-14 Standard Specification and Test Method for Metallic Bone Plates |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 11-297 |
| 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 and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates.
1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system.
1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application.
1.4 This document includes the following test methods used in determining the following bone plate mechanical performance characteristics:
1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates-Annex A1, and
1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates-Annex A2.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.4540 | Bender | Class 1 | HXW |
| §888.4540 | Instrument, Bending Or Contouring | Class 1 | HXP |
| §888.3030 | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class 2 | KTT |
| §888.3030 | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Class 2 | LXT |
| §888.3030 | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Class 2 | KTW |
| §888.3030 | Appliance, Nail/Blade/Plate Combination, Single Component | Class 2 | KWK |
| §888.3030 | Condylar Plate Fixation Implant | Class 2 | JDP |
| §888.3030 | Plate, Fixation, Bone | Class 2 | HRS |
| There is no relevant guidance developed at this time. |