Cleared Special

K091253 - THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS

K091253 is an FDA 510(k) clearance for THORACOLUMBAR PLATE, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 36-day FDA review.

K091253 · K2m, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2009
Decision
36d
Days
Class 2
Risk

K091253 is an FDA 510(k) clearance for the THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRA.... Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on June 4, 2009 after a review of 36 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 K2m, Inc. devices

FDA 510(k) Submission Details - K091253

510(k) Number K091253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2009
Decision Date June 04, 2009
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
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 621
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K091253.
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
EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
K090415 · Eminent Spine · Jun 2009
NUVASIVE LATERAL PLATE SYSTEM
K091071 · Nuvasive, Inc. · May 2009
PIONEER LUMBAR PLATE SYSTEM
K090222 · Pioneer Surgical Technology · Apr 2009