ASTM F382-14

Standard Organization:

ASTM F382-14
Standard Specification and Test Method for Metallic Bone Plates

Recognition Date2016-04-04
Recognition List041
Recognition Number11-297
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

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

There is no relevant guidance developed at this time.


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