Cleared Special

K092108 - TRUSS THORACOLUMBAR PLATE SYSTEM

K092108 is an FDA 510(k) clearance for TRUSS 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 30-day FDA review.

K092108 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
30d
Days
Class 2
Risk

K092108 is an FDA 510(k) clearance for the TRUSS 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 August 13, 2009 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

FDA 510(k) Submission Details - K092108

510(k) Number K092108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date August 13, 2009
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.

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 640
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K092108.
COMET ANTERIOR CERVICAL PLATE SYSTEM
K090751 · Apollo Spine, Inc. · Oct 2009
INTERPLATE C
K092070 · Rsb Spine, LLC · Oct 2009
CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE
K091134 · Custom Spine, Inc. · Aug 2009
CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM
K091396 · Cardo Medical Corp. · Aug 2009
SYNTHES ORACLE PLATE
K091159 · Synthes Spine · Jul 2009
SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM
K091044 · Spinal USA · Jul 2009