K250920 - Arthrex Spine Compression FT Screw (FDA 510(k) Clearance)

K250920 is an FDA 510(k) clearance for the Arthrex Spine Compression FT Screw. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 22, 2025 after a review of 56 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.

View all Arthrex, Inc. devices