| ASTM F1717-18 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
| Recognition Number | Orthopedic |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 11-345 |
| 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 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.
1.5 Some spinal constructs may not be testable in all test configurations.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3070 | Orthosis, Spinal Pedicle Fixation | Class 2 | MNI |
| §888.3070 | Orthosis, Spondylolisthesis Spinal Fixation | Class 2 | MNH |
| §888.3070 | Thoracolumbosacral Pedicle Screw System | Class 2 | NKB |
| §888.3060 | Appliance, Fixation, Spinal Intervertebral Body | Class 2 | KWQ |
| §888.3050 | Appliance, Fixation, Spinal Interlaminal | Class 2 | KWP |
| §888.3075 | Posterior Cervical Screw System | Class 2 | NKG |
| Guidance for Industry and FDA Staff - Spinal System 510(k)s, Issued May 2004 Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, Issued January 2000 |