Cleared Special

K023438 - MODIFICATION TO MONARCH SPINE SYSTEM

K023438 is an FDA 510(k) clearance for MODIFICATION TO MONARCH SPINE SYSTEM, manufactured by Depuyacromed. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 29-day FDA review.

K023438 · Depuyacromed · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
29d
Days
Class 2
Risk

K023438 is an FDA 510(k) clearance for the MODIFICATION TO MONARCH SPINE SYSTEM. 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 November 13, 2002 after a review of 29 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 - K023438

510(k) Number K023438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date November 13, 2002
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 K023438.
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · Blackstone Medical, Inc. · Jun 2003
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383 · Depuyacromed · Feb 2003
MONARCH SPINE SYSTEM
K024348 · Depuyacromed · Jan 2003
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K023204 · Ebi, L.P. · Oct 2002
ENDIUS TITLE SPINAL FIXATION SYSTEM
K021881 · Endius, Inc. · Jul 2002
COLORADO 2 SPINAL SYSTEM
K020247 · Medtronic Sofamor Danek, Inc. · Jul 2002