| ASTM F564-10 (Reapproved 2015) Standard Specification and Test Methods for Metallic Bone Staples |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 11-228 |
| 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 covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples.
1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:
1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples-Annex A1.
1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples-Annex A2.
1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples-Annex A3.
1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples-Annex A4.
| 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 | Plate, Fixation, Bone | Class 2 | HRS |
| §888.3030 | Staple, Fixation, Bone | Class 2 | JDR |
| There is no relevant guidance developed at this time. |