Cleared Special

K120092 - PLYMOUTH THORACOLUMBAR PLATE SYSTEM

K120092 is an FDA 510(k) clearance for PLYMOUTH THORACOLUMBAR PLATE SYSTEM, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 93-day FDA review.

K120092 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Apr 2012
Decision
93d
Days
Class 2
Risk

K120092 is an FDA 510(k) clearance for the PLYMOUTH THORACOLUMBAR PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on April 13, 2012 after a review of 93 days - within the typical 510(k) review window.

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. 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

FDA 510(k) Submission Details - K120092

510(k) Number K120092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2012
Decision Date April 13, 2012
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 612
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K120092.
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