Intervertebral body fusion devices (IBFDs) are typically strut based or hollow structures in a geometric shape with teeth on the caudal and cephalad surfaces. By providing structural support, IBFDs reinforce the spine’s anterior column. An intervertebral body fusion device is used in clinical settings as one of the treatments for degenerative disc disease. They are surgically implanted spinal spacers comprised of either single or multiple components. Materials used typically include titanium and approved polymers, such as PEEK.
ASTM F2077, issued by the American Society for Testing and Materials (ASTM) is used to evaluate the mechanical performance of an intervertebral body fusion device when implanted into the body. These in vitro tests allow for a standardized loading process to be applied and analyzed.
ASTM F2077 incorporates both fatigue and static testing methods for testing and evaluating intervertebral body fusion devices. These methods determine a device’s mechanical properties, specific to the cervical, and lumbar regions of the spine. Depending on the device’s intended spine location, dynamic and static axial compression, shear compression, and/or torsion mode tests are performed.
For static testing, the disc is simulated with a gap between two steel blocks having been prepared to hold the device. Static testing methods include compression, shear, and torsion evaluation along with subsidence (ASTM F2267) as needed.