Cleared Traditional

K253190 - CORUS-LX Implant (FDA 510(k) Clearance)

K253190 · Providence Medical Technology, Inc. · Orthopedic device
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Nov 2025
Decision
55d
Days
-
Risk

K253190 is an FDA 510(k) clearance for the CORUS-LX Implant. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on November 20, 2025 after a review of 55 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 Providence Medical Technology, Inc. devices

Submission Details

510(k) Number K253190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2025
Decision Date November 20, 2025
Days to Decision 55 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Consultant

R. Dubois Consulting, LLC
Roxanne Dubois

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 75
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K253190.
DiversiVy™ Facet Screw System
K253432 · Vy Spine, LLC · Mar 2026
Ion-C
K251714 · SurGenTec, LLC · Jan 2026
FFX Facet Fixation System
K250679 · Sc Medica · Dec 2025
FFX Facet Fixation System
K252153 · Sc Medica · Oct 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · Providence Medical Technology, Inc. · Jul 2025
Arthrex Spine Compression FT Screw
K250920 · Arthrex, Inc. · May 2025