Cleared Traditional

K183060 - CervAlign Anterior Cervical Plate System

K183060 is the FDA 510(k) clearance for CervAlign Anterior Cervical Plate System by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K183060 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic device
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Jan 2019
Decision
76d
Days
Class 2
Risk

K183060 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. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on January 17, 2019 after a review of 76 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. (Dba Rti Surgical, Inc.) devices

Submission Details

510(k) Number K183060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2018
Decision Date January 17, 2019
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 421
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K183060.
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System
K182885 · Medtronic Sofamor Danek USA, Inc. · Feb 2019
SECULOK™ ACP System
K190053 · U&I Corporation · Feb 2019
Pinehurst Anterior Cervical Plate System
K181190 · Signature Orthopaedics Pty, Ltd. · Jan 2019
4CIS® Pinehurst Anterior Cervical Plate system
K182489 · Solco Biomedical Co., Ltd. · Jan 2019
Raven Lumbar Plate System
K183214 · Choicespine, LP · Jan 2019
Met One Czar Anterior Cervical Plate System
K180772 · Met One Technologies · Dec 2018