Cleared Traditional

K121078 - VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM

K121078 is an FDA 510(k) clearance for VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Accel Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K121078 · Accel Spine · Orthopedic device
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Sep 2012
Decision
157d
Days
Class 2
Risk

K121078 is an FDA 510(k) clearance for the VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Accel Spine (Dallas, US). The FDA issued a Cleared decision on September 13, 2012 after a review of 157 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 Accel Spine devices

FDA 510(k) Submission Details - K121078

510(k) Number K121078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2012
Decision Date September 13, 2012
Days to Decision 157 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 122d · This submission: 157d
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 491
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K121078.
ZOU ANTERIOR LUMBAR PLATE SYSTEM
K121791 · Corelink, LLC · Nov 2012
NUVASIVE SAGE LATERAL PLATE SYSTEM
K121815 · Nuvasive, Inc. · Oct 2012
ARCHON ANTERIOR CERVICAL PLATE SYSTE,
K122910 · Nu Vasive, Incorporated · Oct 2012
QUINTEX CERVICAL PLATING SYSTEM
K121801 · Aesculap Implant Systems, LLC · Sep 2012
RELIANCE ANTERIOR CERVICAL PLATE SYSTEM
K122216 · Reliance Medical Systems, LLC · Sep 2012
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
K121658 · Orthofix, Inc. · Jul 2012