Cleared Traditional

K243865 - AERO MIS Facet Fusion System (FDA 510(k) Clearance)

K243865 · Aurora Spine · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
97d
Days
-
Risk

K243865 is an FDA 510(k) clearance for the AERO MIS Facet Fusion System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Aurora Spine (Carlsbad, US). The FDA issued a Cleared decision on March 24, 2025 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Aurora Spine devices

Submission Details

510(k) Number K243865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2024
Decision Date March 24, 2025
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Consultant

Medical Device Development
Jeremi Leasure

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 K243865.
DiversiVy™ Facet Screw System
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K252153 · Sc Medica · Oct 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · Providence Medical Technology, Inc. · Jul 2025