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 clearance. Our experts work with a variety of porous or hollow spinal implants:
- Shapes
- Materials
- Intended locations
- Methods of application
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.
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Medical Device Testing
ASTM Testing
- ASTM F1044 Shear Testing of CaP and Metallic Coatings
- ASTM F1160 Shear and Bending Fatigue of Coatings
- ASTM F1264 Intramedullary Fixation Device Testing
- ASTM F1357 Articulating Total Wrist Implant Testing
- ASTM F1378 Shoulder Prostheses Testing
- ASTM F1541 ESFD Testing
- ASTM F1672 Patellar Prosthesis Testing
- ASTM F1714 Gravimetric Wear Assessment of Prosthetic Hip Design in Simulator Device Testing
- ASTM F1717 Spinal Implant Testing
- ASTM F1781 Elastomeric Flexible Hinge Finger Total Joint Implants Testing
- ASTM F1798 Spinal Implant Subassembly Testing
- ASTM F1820 Modular Acetabular Device Strength Testing
- ASTM F1829 Glenoid Locking Mechanism Shear Testing
- ASTM F1875 Fretting Corrosion Testing of Hip Implant Interfaces
- ASTM 2009 Modular Prostheses Taper Connection Testing
- ASTM F2025 Wear Assessment of Polymeric Components
- ASTM F2028 Glenoid Loosening Testing
- ASTM F2077 Intervertebral Body Fusion Device Testing
- ASTM F2183 Small Punch Testing
- ASTM F2193 Spinal Fixation Components
- ASTM F2267 Measuring Subsidence of Intervertebral Fusion Devices
- ASTM F2346 Standard and Dynamic Testing of Artificial Intervertebral Discs
- ASTM F2423 Wear and Fatigue Testing of Total Disc Prostheses
- ASTM F2502 Absorbable Plate and Screw Testing
- ASTM F2554 CAS System Precision Testing
- ASTM F2624 Static, Dynamic, and Wear Testing of Extra-Discal Spinal Implants
- ASTM F2624 Spinal Implant Dynamic Testing
- ASTM F2694 Lumbar Total Facet Prosthesis Testing
- ASTM F2706 Spinal Implant Fatigue Testing
- ASTM F2789 Mechanical and Functional Characterization of Nucleus Devices
- ASTM F2790 Static and Dynamic Testing of Total Facet Prostheses
- ASTM F382 Metallic Bone Plates Testing
- ASTM F384 Angled Orthopedic Fixation Testing
- ASTM F543 Metallic Medical Bone Screw Testing
- ASTM F564 Metallic Bone Staple Testing
ISO Testing
- Biocompatibility Testing for Medical Devices ISO 10993
- ISO-10328 Structural Testing of Lower Limb Prosthetics
- ISO 10993 Biocompatibility
- ISO 10993 Biocompatibility Testing
- ISO 10993 Testing
- ISO 10993 Testing Lab
- ISO 18192-1 Wear Testing for Intervertebral Disc Prostheses
- ISO 12189 Fatigue Testing of Flexible Spinal Implants
Medical Device Testing
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