Cleared Traditional

K142212 - Pyrenees Cervical Plate System

K142212 is an FDA 510(k) clearance for Pyrenees Cervical Plate System, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K142212 · K2m, Inc. · Orthopedic device
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May 2015
Decision
262d
Days
Class 2
Risk

K142212 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, Inc. (Leesburg, US). The FDA issued a Cleared decision on May 1, 2015 after a review of 262 days - an extended review cycle.

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.

View all K2m, Inc. devices

FDA 510(k) Submission Details - K142212

510(k) Number K142212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2014
Decision Date May 01, 2015
Days to Decision 262 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
140d slower than avg
Panel avg: 122d · This submission: 262d
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 602
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K142212.
Captiva Spine SmartLOX Cervical Plate System
K141332 · Captiva Spine · Jun 2015
Azure Anterior Cervical Plate System
K143028 · Orthofix, Inc. · May 2015
Blue Mountain Cervical Plate System
K150036 · Spineway · May 2015
FortiBridge Anterior Cervical Plate System
K143706 · Nanovis Spine, LLC · Apr 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