Cleared Traditional

K111132 - GENESYS SPINE ANTERIOR CERVICAL PLATE S...

K111132 is the FDA 510(k) clearance for GENESYS SPINE ANTERIOR CERVICAL PLATE S... by Genesys Spine. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K111132 · Genesys Spine · Orthopedic device
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Dec 2011
Decision
231d
Days
Class 2
Risk

K111132 is an FDA 510(k) clearance for the GENESYS SPINE ANTERIOR CERVICAL 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 December 9, 2011 after a review of 231 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 K111132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2011
Decision Date December 09, 2011
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
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 K111132.
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
K120092 · Globus Medical, Inc. · Apr 2012
LEXUS ANTERIOR CERVICAL PLATE SYSTEM
K113509 · L & K Biomed Co., Ltd. · Jan 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329 · K2m, Inc. · Jan 2012
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
K112724 · Medos International SARL · Nov 2011
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
K111796 · Zimmer Spine, Inc. · Oct 2011
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K111135 · K2m, Inc. · Aug 2011