FDA releases performance criteria for spinal plating systems
The FDA published guidance on performance criteria for spinal plating systems being submitted for 510(k) approval using the safety and performance-based pathway.
Spinal plates subject to this guidance include anterior cervical or anterior/lateral thoracolumbar spinal plating systems intended for fixation to vertebral bodies for the purpose of stabilizing the spine for fusion, according to the guidance document.
The document noted devices appropriate for submission through the safety and performance-based pathway do not need to have direct comparison testing against a legally marketed predicate device to demonstrate substantially equivalent performance characteristics. The FDA recommended a results summary be provided for all tests evaluated in addition to other submission information identified for each test or evaluation.
For testing, the FDA recommended mechanical testing, including static compression bending, static torsion and dynamic compression bending, be performed in conformance with the currently recognized version of the Standard Test Methods for Spinal Implant Constructs in Vertebrectomy Model. The document noted all testing on plate system designs should represent worst-case final design versions and a rationale identifying how the worst-case design was identified should be provided. The FDA also recommended sterilization and reprocessing validation testing to demonstrate the cleanliness and sterility of or the ability to clean and sterilize the device and device-specific instruments, as well as biocompatibility testing.