Guide on Facet Screw Systems Performance Criteria

FDA has release a draft guidance entitled Facet Screw Systems — Performance Criteria for Safety and Performance Based Pathway. The screw systems that are the subject of the guidance comprise metallic bone screws and optional washer components. The devices are unclassified and are identified with the product code MRW (system, facet screw spinal device). They are intended for bilateral immobilization of facet joints to stabilize the spine as an aid to fusion. The optional washer components are intended for use with the facet screw to aid in load distribution at the screw head/bone interface.

The guidance provides performance criteria for the screw systems to support those fileing 510(k)s relying on the Performance Based Pathway. Under this framework, submitters have the option to use the performance criteria to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.