| ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 11-276 |
| 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 test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants.
1.2 The purpose of this test method is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this test method to address the analysis of spinal implant constructs or subconstructs or to define levels of performance of spinal implants as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs.
1.3 This test method sets out definitions for use in measuring the strength of component interconnections of spinal implants, possible test methods themselves, and the reporting of test results.
| Regulation Number | Device Name | Device Class | Product Code |
| PEDICLE SCREW SPINAL SYSTEM | |||
| §888.3070 | Orthosis, Spinal Pedicle Fixation | Class 2 | MNI |
| §888.3070 | Orthosis, Spondylolisthesis Spinal Fixation | Class 2 | MNH |
| §888.3060 | Appliance, Fixation, Spinal Intervertebral Body | Class 2 | KWQ |
| §888.3050 | Appliance, Fixation, Spinal Interlaminal | Class 2 | KWP |
| IDE | |||
| Unclassified | Spinal Pedicle Screw, Fixation, Appliance System | Class 3 | MCV |
| Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 2000 |