ASTM F2267
Evaluating Spinal Intervertebral Body Fusion Devices Under Axial Compression
Following disc degeneration, intervertebral body fusion devices can be used to help promote arthrodesis of a spinal motion segment. The medical device supports the anterior column while the two vertebral discs grow together and fuse the spine. Intervertebral body fusion is a more widely used technique than intervertebral disc replacement.
ASTM F2267-04, "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression," specifies a static axial-compression test carried out in vitro to provide a mechanical comparison between different fusion implants. Testing is carried out with both metallic blocks and polyurethane blocks.
These tests can be carried out on a universal testing system with the moving actuator mounted in the upper crosshead. However, we recommend using either an ElectroPuls® E10000 Linear-Torsion All-Electric Dynamic Test Instrument or an 8874 servohydraulic testing system. These systems allow specialized test fixtures to be combined with a temperature-controlled bath, providing a stable environment that simulates in vivo conditions. Our testing systems also allow mounting of the Dynacell™ load cell on the end of the moving actuator, to accurately measure subsidence forces.
Review testing details for static, fatigue, and characterization tests of intervertebral body fusion devices, as specified in ASTM F2077.
We recommend reviewing the standard fully to understand all of its requirements.
