Standard Practice for static and Dynamic characterization of motion preserving lumbar total facet prostheses
Please refer to the ASTM website for the most up to date information on ASTM F2790 or visit our Quality Standards page to see additional accredited test standards performed at our certified testing laboratory.
Motion Preserving Lumbar Total Facet Prostheses are an excellent alternative to traditional spinal surgical techniques like spinal fusion. These medical devices are designed to replace the natural facet joints in the spine, eliminating sources of pain and disease while still preserving a patient’s range of motion.
If you or your company is interested in manufacturing or redesigning a Motion Preserving Lumbar Total Facet Prosthesis, it’s important to work with a qualified testing provider like Empirical Technologies Corp. to ensure the device is tested according to ASTM F2790 standards and to get FDA approval the first time.
This is a critical part of verifying the device’s quality, and an essential first step when preparing for FDA approval. Learn more about ASTM F2790 below or contact Empirical Technologies Corp. now to request an estimate.
ASTM F2790 Testing
The ASTM F2790 standard outlines the test methods used to test and verify the quality of Lumbar Total Facet Prostheses (FPs). Depending on the device in question, these implants may replace the natural facets of the spine using a wide variety of different designs including free-floating joints, semi-constrained third body joints, ball-and-socket articulating joints, and metallic load-bearing surfaces.
By replacing the natural facets of the spine, Lumbar Total Facet Prostheses are designed to allow proper motion and support the functional spinal units. They are used to treat facet joint pain, or to replace a diseased or dysfunctional facet joint in the spine.
The prevalence of Lumbar Total Facet Prostheses in medicine has been growing for several years. When properly implanted, these spinal prostheses can improve spine stability, provide relief from pain, and allow for nerve decompression. Unlike other treatments like spinal fusion, this treatment also preserves full spinal mobility and motion.
ASTM F2790 Standard Prosthesis Testing Methods
In all testing methods, the Lumbar Total Facet Prosthesis is firmly connected to test blocks built from polyethylene, and these blocks are clamped in a testing device.
- Mechanical properties under translation – This test provides information about the displacement and mechanical properties of the prosthesis, including strength and stiffness. A constant displacement of up to 25 millimeters/minute is applied in three directions; medial-lateral, superior-inferior, and anterior-posterior.
- Mechanical properties under rotation – This test provides information about the torque-angle-of-rotation curve, including overall strength and stiffness. Up to 60 degrees/minute of torque will be applied to the prosthesis. Lateral bending, axial torsion, and flexion-extension are all considered during this test.
- Dynamic testing – After the above static tests are completed, dynamic tests are done with new specimens for up to 10 million cycles, or whenever the implant fails. Different maximum loads are used until the survival rate between the two loads is less than 10%.
- Wear testing – For up 10 million cycles, the Lumbar Total Facet Prosthesis is subjected to lateral bending, flexion and extension, and axial rotation to the left and right, based on ASTM F2790 requirements. After the test is complete, the test specimens are weighed and analyzed to determine the extent of wear.
Contact Empirical Technologies Corp Today To Get Started With ASTM F2790 Testing
At Empirical Technologies Corp, we have a deep understanding of ASTM F2790 testing requirements, advanced testing machinery for accurate and precise results, and more than 20 years of experience serving our medical device partners. That makes us the best option for Lumbar Total Facet Prosthesis testing.
We can assist with every step of testing a Lumbar Total Facet Prosthesis according to ASTM F2790 standards and we also assist in the process of submitting medical devices for FDA approval.
If you are in need of an expert partner for testing for your medical devices, Empirical Technologies Corp. is the best choice. Contact us online or give us a call at +1 719.457.1144 to request an estimate and get the assistance you need right away.