Cleared Traditional

K132653 - NEOPLATE SPINE ANTERIOR FIXATION SYSTEM

K132653 is an FDA 510(k) clearance for NEOPLATE SPINE ANTERIOR FIXATION SYSTEM, manufactured by Neoortho Productos Orthopedicos S/A. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K132653 · Neoortho Productos Orthopedicos S/A · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
261d
Days
Class 2
Risk

K132653 is an FDA 510(k) clearance for the NEOPLATE SPINE ANTERIOR FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Neoortho Productos Orthopedicos S/A (Aventura, US). The FDA issued a Cleared decision on May 14, 2014 after a review of 261 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 Neoortho Productos Orthopedicos S/A devices

FDA 510(k) Submission Details - K132653

510(k) Number K132653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2013
Decision Date May 14, 2014
Days to Decision 261 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
139d slower than avg
Panel avg: 122d · This submission: 261d
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 K132653.
SKYHAWK LATERAL PLATE SYSTEM
K140260 · Orthofix, Inc. · Jul 2014
META-C CERVICAL PLATE
K140361 · Medacta International · Jun 2014
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K140611 · Zimmer Spine, Inc. · May 2014
RELIANCE ANTERIOR CERVICAL PLATE
K140742 · Reliance Medical Systems, LLC · Apr 2014
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K133567 · Globus Medical, Inc. · Feb 2014
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K133475 · Nexxt Spine, LLC · Dec 2013