Cleared Traditional

K211408 - CervAlign Anterior Cervical Plate System

K211408 is the FDA 510(k) clearance for CervAlign Anterior Cervical Plate System by Pioneer Surgical Technology, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K211408 · Pioneer Surgical Technology, Inc. · Orthopedic device
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Jun 2021
Decision
48d
Days
Class 2
Risk

K211408 is an FDA 510(k) clearance for the CervAlign® Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on June 23, 2021 after a review of 48 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 Pioneer Surgical Technology, Inc. devices

Submission Details

510(k) Number K211408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2021
Decision Date June 23, 2021
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K211408.
Shoreline Threaded TruProfile® Plate
K211903 · SeaSpine Orthopedics Corporation · Aug 2021
Prase-C Anterior Cervical Plate System
K211205 · Gbs Commonwealth Co., Ltd. · Aug 2021
Fixxsure Anterior Lumbar Plate and Screw System
K211932 · Oak Tree Engineering, LLC · Jul 2021
PANAMA™ Anterior Cervical Plate (ACP) System
K210182 · Flospine · Apr 2021
APOLLO Anterior Cervical Plate (ACP) System
K210325 · Aurora Spine, Inc. · Mar 2021
Cure 2.0 Anterior Cervical Plate (ACP) System
K210286 · Meditech Spine, LLC · Mar 2021