Cleared Traditional

K133911 - GENESYS SPINE ANTERIOR BUTTRESS PLATE S...

K133911 is the FDA 510(k) clearance for GENESYS SPINE ANTERIOR BUTTRESS PLATE S... by Genesys Spine. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K133911 · Genesys Spine · Orthopedic device
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Sep 2014
Decision
254d
Days
Class 2
Risk

K133911 is an FDA 510(k) clearance for the GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on September 3, 2014 after a review of 254 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 Genesys Spine devices

Submission Details

510(k) Number K133911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date September 03, 2014
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
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 436
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K133911.
LITe Plate System
K142699 · Stryker Corporation · Dec 2014
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
K141632 · Medtronic Sofamor Danek USA, Inc. · Dec 2014
OPTIO-C ANTERIOR CERVICAL SYSTEM
K141500 · Zimmer Spine, Inc. · Sep 2014
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
K140417 · Medtronic Sofamor Danek, Inc. · Jul 2014
SKYHAWK LATERAL PLATE SYSTEM
K140260 · Orthofix, Inc. · Jul 2014
META-C CERVICAL PLATE
K140361 · Medacta International · Jun 2014