Cleared Traditional

K211712 - 3° Anterior Cervical Plating System

K211712 is an FDA 510(k) clearance for 3° Anterior Cervical Plating System, manufactured by Orthofix US, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K211712 · Orthofix US, LLC · Orthopedic device
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Feb 2022
Decision
253d
Days
Class 2
Risk

K211712 is an FDA 510(k) clearance for the 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System.... Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Orthofix US, LLC (Lewisville, US). The FDA issued a Cleared decision on February 11, 2022 after a review of 253 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 Orthofix US, LLC devices

FDA 510(k) Submission Details - K211712

510(k) Number K211712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2021
Decision Date February 11, 2022
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K211712.
AccuFit Lateral 2-Hole Plate
K220324 · Precision Spine, Inc. · Mar 2022
IMPEACE and IMPEACE-Uni Anterior Cervical Plate System
K220379 · Medynus, Inc. · Mar 2022
Aspiron S ACP System
K220147 · U&I Corporation · Feb 2022
Cyclops™ Anterior Cervical Plate System
K213901 · Degen Medical · Jan 2022
Vy Spine™ VyWasher™ Buttress System
K213219 · Vy Spine, LLC · Dec 2021
Xenco Medical Multilevel CerviKit
K213456 · Xenco Medical, LLC · Dec 2021