Cleared Traditional

K142699 - LITe Plate System

K142699 is an FDA 510(k) clearance for LITe Plate System, manufactured by Stryker Corporation. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K142699 · Stryker Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
100d
Days
Class 2
Risk

K142699 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 Corporation (Allendale, US). The FDA issued a Cleared decision on December 31, 2014 after a review of 100 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K142699

510(k) Number K142699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date December 31, 2014
Days to Decision 100 days
Submission Type Traditional
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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 662
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K142699.
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
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
K141632 · Medtronic Sofamor Danek USA, Inc. · Dec 2014
TRANSOM ANTERIOR CERVICAL PLATE
K142060 · Neurostructures, Inc. · Nov 2014
NAKOMA ACP
K141993 · Alliance Partners, LLC · Nov 2014
K142699 · LITe Plate System
Download PDF FDA Summary Stryker Corporation