The FDA 2007 guidance document applies to interbody fusion cages, which are implanted in a variety of materials (including titanium alloys and polymers) with a single or multiple spinal devices. The device is inserted into the cervical or lumbosacral space for intervertebral fusion.
The FDA 2007 guidance document applies to interbody fusion cages, which are implanted in a variety of materials (including titanium alloys and polymers) with a single or multiple spinal devices. The device is inserted into the cervical or lumbosacral space for intervertebral fusion.
Mechanical Test Summary: The FDA guidelines recommend that the composition of the test structure be considered for the final design version of the worst case (eg, most likely to fail). The component being tested should include the worst case of the reference design, materials, and manufacturing related processes.
For interbody fusion cages, the FDA recommends the following complete test reports: static and dynamic torsion tests for interbody cage devices; static and dynamic axial compression and compression shear tests for lumbar and cervical interbody fusion devices, and sedimentation tests. Depending on the specific design (eg front cord design), material (polymer, composite) and/or joining method, additional tests may be required for a given interbody cage, such as dynamic torsion testing. , extrusion test and creep test.
Static and Dynamic Testing: The FDA recommends that static and dynamic structural testing should include at least six samples containing the worst case configuration. The most common tests for static and dynamic structural tests are based on the ASTM F2077-03 interbody fusion cage test method. ASTM F2077-03 provides a standard for static and dynamic mechanical properties testing of interbody fusion devices. If your interbody fusion cage is produced from a material other than a polymer, additional testing is required in accordance with ASTM F2077-03. .
The dynamic test should include at least 6 samples containing the worst case configuration, and the FDA defines the end of the structural functional failure or the achievement of 5 million cycles without failure, and uses this result to compare data from the disc cage. A minimum of two samples were tested with the lowest load, thereby establishing a durability limit.
Settlement test: The FDA recommends measuring the method or equivalent of measuring the sedimentation load of an interbody cage under static axial compression in accordance with ASTM F2267. The ASTM F2267 standard is based on metal implants and may not be suitable if your implanted device is of other materials. Therefore, if your interbody fusion cage is made of polymeric materials or other materials, additional testing and/or improvement in accordance with ASTM F22687 is necessary.
Test report: According to FDA guidelines, a complete test report should be provided, including: identification of the worst case interbody fusion cage; consideration of the worst case basis of the interbody fusion cage; selection of the loading mode (eg axial, Bending, torsion, etc.; test results; results are discussed based on the in vivo and clinical presentation of the components.
ASTM F2267 interbody fusion cage axial compression test:
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