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 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 now to request an estimate.
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.
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.
At Empirical Technologies, 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.