Cleared Special

K121732 - CANOPY LAMINOPLASTY FIXATION SYSTEM

K121732 is the FDA 510(k) clearance for CANOPY LAMINOPLASTY FIXATION SYSTEM by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code NQW) cleared through the Special 510(k) pathway after a 140-day FDA review.

K121732 · Globus Medical, Inc. · Orthopedic device
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Oct 2012
Decision
140d
Days
Class 2
Risk

K121732 is an FDA 510(k) clearance for the CANOPY LAMINOPLASTY FIXATION SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on October 31, 2012 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K121732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2012
Decision Date October 31, 2012
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
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 - NQW Orthosis, Spine, Plate, Laminoplasty, Metal

All 19
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K121732.
Choice Spine Laminoplasty™ Fixation System
K173215 · Choicespine, LP · Jan 2018
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
K171413 · Globus Medical, Inc. · Jul 2017
Xspan Laminoplasty Fixation System
K160114 · X-Spine Systems, Inc. · Mar 2016
ESCALATE LAMINOPLASTY SYSTEM
K113802 · Stryker Spine · Apr 2012
MOUNTAINEER LAMINOPLASTY SYSTEM
K091994 · Depuy Spine, Inc. · Jan 2010
LAMINOPLASTY FIXATION SYSTEM
K091623 · Nuvasive, Inc. · Oct 2009