Cleared Special

K152281 - Pyrenees Cervical Plate System

K152281 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 Special 510(k) pathway after a 43-day FDA review.

K152281 · K2m · Orthopedic device
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Sep 2015
Decision
43d
Days
Class 2
Risk

K152281 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 September 24, 2015 after a review of 43 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 devices

FDA 510(k) Submission Details - K152281

510(k) Number K152281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2015
Decision Date September 24, 2015
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
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 583
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K152281.
ATLANTIS Anterior Cervical Plate System
K152623 · Medtronic Sofamor Danek USA, Inc. · Nov 2015
Amendia Cervical Plate System
K152455 · Amendia, Inc. · Oct 2015
Renovis Anterior Cervical Plate System
K152193 · Renovis Surgical Technologies, Inc. · Sep 2015
Pyrenees Cervical Plate System
K152015 · K2m, Inc. · Sep 2015
Hyper-C Anterior Cervical Plate System
K150759 · Degen Medical · Jul 2015
ACP 1 Anterior Cervical Plating System
K150700 · Stryker Corporation · Jul 2015