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FDA Adds Bone Screws and Spine Plates to Alternative 510(k) Pathway

As 2020 came to a close, FDA announced that two orthopedic device types could utilize the Safety and Performance Based Pathway for regulatory clearance. The Agency gave nods to orthopedic non-spinal metallic bone screws and washers and spinal plating systems by issuing final guidance documents.

The Safety and Performance Based Pathway is an abbreviated 510(k) pathway for well-understood device types. The Agency finalized the pathway in 2019 with the expectation that it could speed market access for devices with moderate risk.

The Safety and Performance Based Pathway allows device manufacturers to use FDA-identified performance criteria to demonstrate their device is as safe and effective as a predicate device.

For example, FDA notes that it may be more burdensome for a device manufacturer to conduct testing against an appropriate predicate device to demonstrate equivalence of performance and technological characteristics than to demonstrate that their device meets FDA’s applicable performance criteria.

FDA issues final guidance when it adds a new device type to the pathway’s list. The guidance outlines the device’s intended use, device design characteristics and appropriate testing to complete.

The latest update included bone screws for orthopedic non-spinal fracture fixation, osteotomy or small joint fusion or arthrodesis, along with washers that are intended for use with bone screws to aid in load distribution at the screw head/bone interface. Also added to the list were spinal plating systems intended for fixation to vertebral bodies (anteriorly in the cervical spine or anteriorly/laterally in the thoracolumbar spine) for the purpose of stabilizing the spine for fusion.

The Safety and Performance Based Pathway is voluntary. FDA plans to expand the list of devices that meet the alternative regulatory criteria and encourages industry to make suggestions for devices that include comprehensive FDA-recognized consensus standards.


 

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