Cleared Special

K021148 - MONARCH SPINE SYSTEM COMMERCIALLY PURE ...

K021148 is an FDA 510(k) clearance for MONARCH SPINE SYSTEM COMMERCIALLY PURE ..., manufactured by Depuyacromed. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 28-day FDA review.

K021148 · Depuyacromed · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
28d
Days
Class 2
Risk

K021148 is an FDA 510(k) clearance for the MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD. 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 May 8, 2002 after a review of 28 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 - K021148

510(k) Number K021148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2002
Decision Date May 08, 2002
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 K021148.
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
K021880 · Depuyacromed · Jun 2002
EQUATION FIXATION SYSTEM
K013962 · Medtronic Sofamor Danek, Inc. · Jun 2002
TSRH SPINAL SYSTEM
K020699 · Medtronic Sofamor Danek, Inc. · May 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
K020674 · Blackstone Medical, Inc. · Apr 2002
EBI OMEGA21 SPINAL FIXATION SYSTEM
K020681 · Ebi, L.P. · Apr 2002
OSTEONICS SPINAL SYSTEM
K020293 · Howmedica Osteonics Corp. · Feb 2002