Cleared Traditional

K153526 - Pyrenees Cervical Plate System

K153526 is an FDA 510(k) clearance for Pyrenees Cervical Plate System, manufactured by K2m. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K153526 · K2m · Orthopedic device
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Apr 2016
Decision
140d
Days
Class 2
Risk

K153526 is an FDA 510(k) clearance for the Pyrenees Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by K2m (Leesburg, US). The FDA issued a Cleared decision on April 27, 2016 after a review of 140 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.

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FDA 510(k) Submission Details - K153526

510(k) Number K153526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2015
Decision Date April 27, 2016
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
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 583
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K153526.
ZION Anterior Cervical Fixation System
K160702 · Astura Medical · Aug 2016
Belvedere™ Lateral Plating System
K153097 · Neurostructures, Inc. · Jul 2016
Cure™ Anterior Cervical Plate (ACP) System
K160604 · Meditech Spine, LLC · Jul 2016
White Pearl Preferred Angle Anterior Cervical Plate
K160522 · Osseus Fusion Systems, LLC · Apr 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · Spineart · Mar 2016
Z-Span Plate System
K160362 · Zavation, LLC · Mar 2016