ASTM F2267-04(2018),Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.
ASTM F2267-04(2018) specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.
This standard is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices.
Summary of Test Method
4.1 To measure load induced subsidence,a test method is proposed for the axial compression of intervertebral body fusion devices specific to the lumbar, thoracic, and cervicalspine.
4.2 The axial compressive subsidence testing of the in-tervertebral body fusion device will be conducted in a simulated motion segment via a gap between two polyurethane foam blocks.
4.3 Grade 15 foam shall be employed conforming to Specification F1839.
Designation: F2267-04 ( Reapproved 2018)