ASTM F2267 Measuring Subsidence of Intervertebral Fusion Devices
ATS can help medical device manufacturers submit reliable and ASTM F2267-compliant spinal implants for FDA approval. Intervertebral body fusion devices promote arthrodesis between two adjacent vertebrae, intervertebral disks, and facet joints. A successful implant eliminates pain upon vertebral movement by fusing two vertebrae into a single bone. However, implant failure may occur due to deficient design.
As a result, the American Society for Testing and Materials (ASTM) released standard F2267, which recommends static axial compression tests in vitro to isolate a device’s subsidence characteristics. Subsidence refers to a product’s tendency to slope into surrounding vertebral bodies under static loads. An implant with high subsidence can deform and sink over time, increasing pressure and causing inflammation in the inferior vertebrae and joints.
Medical Device Testing with the ATS FoC
Before presenting an intervertebral body fusion device to the FDA for in vivo testing, manufacturers turn to third-party labs to qualify the product. Operating multiple ISO/IEC 17025-accredited labs, the ATS FoC is a proven asset to medical device testing.
We facilitate informed decision-making so clients may choose to make design changes to an intervertebral device before submitting the product for FDA approval. Our experts work with a variety of porous or hollow spinal implants:
ASTM F2267 Procedure
To perform ASTM F2267, we fit an axial compression machine with rigid metal or polyurethane foam blocks designed to complement the medical device. The difference in block materials helps our experts identify the stiffness of the medical device assembly.
Next, the machine applies the load at 0.1 mm/s until functional failure occurs. After testing, our experts can analyze the stiffness measurements to calculate the implant’s subsidence. Our analysis helps clients identify the steps needed to reach the market faster.
About the ATS FoC
The ATS FoC runs multiple ISO/IEC 17025-accredited labs capable of calibration and mechanical, nondestructive, chemical, and electrical testing. We deliver high-quality customer service through our responsive team of experts, thorough analysis, and quick turnaround rate.
Call +1 (888) 287-5227 to learn more about how the ATS FoC can help qualify your medical devices with ASTM F2267 compliance.