ASTM F2077 Characterization and Fatigue of Spinal Intervertebral Body Fusion Devices

Intervertebral Body Fusion devices are used to promote arthrodesis of a spinal motion segment, following disc degeneration. The implant acts as a support of the anterior column whilst the two vertebral discs grow together and fuse the spine. Intervertebral Body Fusion is an alternative technique to that of Intervertebral Disc replacement.

ASTM F2077 – 03 “Test Methods for Intervertebral Body Fusion Devices” specifies a number of different static and dynamic tests to provide a mechanical comparison between different fusion devices. The tests include:

• Axial-Compression
• Compression-Shear
• Torsion Testing

An axial-torsion system, such as the 8874 servohydraulic or the ElectroPuls™ E10000 Linear-Torsion All-Electric Dynamic Test Instrument, allows manufacturers and researchers to conduct both the static and fatigue testing on a range of implant designs. These systems are combined with a temperature controlled bath, which provides a stable environment for simulation of in vivo conditions.

With the use of specialized test fixtures, the combined axial-torsional actuator in the crosshead of either the 8874 or the E10000 allows for conduction characterization in axial compression, compression-shear, or compression-torsion tests modes. Our testing systems allow for mounting of the Biaxial Dynacell™ load cell on the end of the moving axial-torsional actuator and can automatically compensate for errors caused by inertial loading.

Review alternative test for intervertebral body fusion devices is specified in ASTM F2267.

We recommend that you review the standard to fully understand its requirements.