| ASTM F2077-14 Test Methods for Intervertebral Body Fusion Devices |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 11-288 |
| 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 materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.
1.3 The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies.
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3080 | Intervertebral Fusion Device With Bone Graft, Cervical | Class 2 | ODP |
| §888.3080 | Intervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | MAX |
| §888.3080 | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class 2 | OVE |
| §888.3080 | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class 2 | OVD |
| §888.3060 | Spinal Vertebral Body Replacement Device | Class 2 | MQP |
| Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007 Guidance for Industry and FDA Staff Spinal System 510(k)s, May 3, 2004 |