Cleared Traditional

V3 Segmental Plating System (K182418) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182418 · Atlas Spine, Inc. · Orthopedic device
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Nov 2018
Decision
85d
Days
Class 2
Risk

K182418 is an FDA 510(k) clearance for the V3 Segmental Plating System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on November 29, 2018 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Atlas Spine, Inc. devices

Submission Details

510(k) Number K182418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2018
Decision Date November 29, 2018
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
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 Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 244
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K182418.
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K180772 · Met One Technologies · Dec 2018
PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems
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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
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SECULOK™ ACP System
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