Cleared Special

K013294 - MONARCH SPINAL SYSTEMS

K013294 is an FDA 510(k) clearance for MONARCH SPINAL SYSTEMS, manufactured by Depuyacromed. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 7-day FDA review.

K013294 · Depuyacromed · Orthopedic device
Download Printable Device Report (PDF)
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Oct 2001
Decision
7d
Days
Class 2
Risk

K013294 is an FDA 510(k) clearance for the MONARCH SPINAL SYSTEMS. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on October 9, 2001 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Depuyacromed devices

FDA 510(k) Submission Details - K013294

510(k) Number K013294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2001
Decision Date October 09, 2001
Days to Decision 7 days
Submission Type Special
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
115d faster than avg
Panel avg: 122d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 156
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K013294.
MODIFICATION TO EBI OMEGA 21 SYSTEM
K014137 · Ebi, L.P. · Jan 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K014076 · Medtronic Sofamor Danek, Inc. · Dec 2001
MODIFICATION TO XIA SPINAL SYSTEM
K013688 · Howmedica Osteonics Corp. · Dec 2001
TIMX SPINAL SYSTEMS
K013295 · Depuyacromed · Oct 2001
MOSS MIAMI SPINAL SYSTEMS
K013296 · Depuyacromed · Oct 2001
ISOLA SPINAL SYSTEMS
K012971 · Depuyacromed · Oct 2001