Cleared Special

FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS (K112756) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K112756 · Globus Medical, Inc. · Orthopedic device
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Oct 2011
Decision
16d
Days
Class 2
Risk

K112756 is an FDA 510(k) clearance for the FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on October 7, 2011 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K112756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2011
Decision Date October 07, 2011
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 44
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K112756.
FORTIFY Corpectomy Spacers
K162315 · Globus Medical, Inc. · Nov 2017
NuVasive(r) Monolith Corpectomy System
K170271 · Nu Vasive, Incorporated · Mar 2017
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
K121107 · Globus Medical, Inc. · Jul 2012
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · Medtronic Sofamor Danek USA, Inc. · Oct 2010
T2 SPINAL SYSTEM
K091883 · Medtronic Sofamor Danek USA, Inc. · Sep 2009
NIKO CORPECTOMY SPACER
K072465 · Globus Medical, Inc. · Oct 2007