Cleared Special

K150449 - LITe Plate System

K150449 is the FDA 510(k) clearance for LITe Plate System by Stryker Corp.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 28-day FDA review.

K150449 · Stryker Corp. · Orthopedic device
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Mar 2015
Decision
28d
Days
Class 2
Risk

K150449 is an FDA 510(k) clearance for the LITe Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Stryker Corp. (Allendale, US). The FDA issued a Cleared decision on March 20, 2015 after a review of 28 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 Stryker Corp. devices

Submission Details

510(k) Number K150449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2015
Decision Date March 20, 2015
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 435
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K150449.
Pyrenees Cervical Plate System
K142212 · K2m, Inc. · May 2015
LnK Anterior Cervical Plate System
K143279 · L & K Biomed Co., Ltd. · Mar 2015
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System
K143626 · Zimmer Spine, Inc. · Mar 2015
Exactech Ambassador
K143576 · Exactech, Inc. · Feb 2015
Aviator Anterior Cervical Plate (ACP) System
K142237 · Stryker Corporation · Jan 2015
NuVasive ALIF Buttress Plate System
K143065 · Nu Vasive, Incorporated · Jan 2015