K222515 - FaSet Fixation System (FDA 510(k) Clearance)

K222515 is an FDA 510(k) clearance for the FaSet Fixation System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Dio Medical Corporation (East Norriton, US). The FDA issued a Cleared decision on October 5, 2022 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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