Cleared Traditional

K133245 - GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM

K133245 is an FDA 510(k) clearance for GENESYS SPINE ANTERIOR CERVICAL PLATE I..., 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 351-day FDA review.

K133245 · Genesys Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
351d
Days
Class 2
Risk

K133245 is an FDA 510(k) clearance for the GENESYS SPINE ANTERIOR CERVICAL PLATE II 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 October 8, 2014 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K133245

510(k) Number K133245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2013
Decision Date October 08, 2014
Days to Decision 351 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
229d slower than avg
Panel avg: 122d · This submission: 351d
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 602
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K133245.
TRANSOM ANTERIOR CERVICAL PLATE
K142060 · Neurostructures, Inc. · Nov 2014
NAKOMA ACP
K141993 · Alliance Partners, LLC · Nov 2014
MAXAN ANTERIOR CERVICAL PLATE SYSTEM
K133518 · Biomet Spine (Aka Ebi, LLC) · Nov 2014
OPTIO-C ANTERIOR CERVICAL SYSTEM
K141500 · Zimmer Spine, Inc. · Sep 2014
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM
K133911 · Genesys Spine · Sep 2014
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
K140417 · Medtronic Sofamor Danek, Inc. · Jul 2014