Cleared Traditional

K111132 - GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM

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

K111132 · Genesys Spine · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K111132

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
Combination Product No
PCCP Authorized No
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.

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 589
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K111132.
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K112206 · Seaspine, Inc. · Jan 2012
LEXUS ANTERIOR CERVICAL PLATE SYSTEM
K113509 · L & K Biomed Co., Ltd. · Jan 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329 · K2m, Inc. · Jan 2012
ZAVATION CERVICAL PLATE SYSTEM
K112533 · Zavation, LLC · Dec 2011
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
K112724 · Medos International SARL · Nov 2011
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
K111796 · Zimmer Spine, Inc. · Oct 2011