Cleared Special

K072465 - NIKO CORPECTOMY SPACER

K072465 is the FDA 510(k) clearance for NIKO CORPECTOMY SPACER by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 30-day FDA review.

K072465 · Globus Medical, Inc. · Orthopedic device
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Oct 2007
Decision
30d
Days
Class 2
Risk

K072465 is an FDA 510(k) clearance for the NIKO CORPECTOMY SPACER. 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 4, 2007 after a review of 30 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 K072465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2007
Decision Date October 04, 2007
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K072465.
X-MESH EXPANDABLE CAGE SYSTEM
K080568 · Depuy Spine, Inc. · May 2008
BENGAL STACKABLE CAGE SYSTEM
K073649 · Depuy Spine, Inc. · Jan 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K080024 · K2m, Inc. · Jan 2008
T2 XVBR SPINAL SYSTEM
K071033 · Medtronic Sofamor Danek · Aug 2007
VERTE-STACK SPINAL SYSTEM
K070173 · Medtronic Sofamor Danek, Inc. · Mar 2007
T2 SCEPTOR SPINAL SYSTEM
K063491 · Medtronic Sofamor Danek · Mar 2007