Cleared Traditional

K182473 - PYRENEES Cervical Plate System

K182473 is the FDA 510(k) clearance for PYRENEES Cervical Plate System by K2m, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K182473 · K2m, Inc. · Orthopedic device
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Dec 2018
Decision
93d
Days
Class 2
Risk

K182473 is an FDA 510(k) clearance for the PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervi.... 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 December 12, 2018 after a review of 93 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.

View all K2m, Inc. devices

Submission Details

510(k) Number K182473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2018
Decision Date December 12, 2018
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Backroads Consulting, Inc.
Karen E. Warden, Ph.D.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K182473.
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Aspida® Anterior Lumbar Plating System
K182808 · Alphatec Spine, Inc. · Nov 2018
ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System
K181846 · Globus Medical, Inc. · Nov 2018