Cleared Traditional

K122049 - NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM

K122049 is an FDA 510(k) clearance for NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM, manufactured by Kinamed, Inc.. The device is a Class 2 Neurology device with product code GWO cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K122049 · Kinamed, Inc. · Neurology device
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Apr 2013
Decision
267d
Days
Class 2
Risk

K122049 is an FDA 510(k) clearance for the NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Kinamed, Inc. (Camarillo, US). The FDA issued a Cleared decision on April 5, 2013 after a review of 267 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kinamed, Inc. devices

FDA 510(k) Submission Details - K122049

510(k) Number K122049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2012
Decision Date April 05, 2013
Days to Decision 267 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 148d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWO Device Classification - Class 2, Special Controls

Product Code GWO Plate, Cranioplasty, Preformed, Alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5320
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 Neurology devices follow this clearance model.

Regulatory Peers - GWO Plate, Cranioplasty, Preformed, Alterable

All 40
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K122049.
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
K140462 · Synthes USA Products, LLC · Jun 2014
UNIVERSAL NEURO 3 SYSTEM
K131775 · Stryker · Oct 2013
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
K123723 · Synthes · Sep 2013
RESORB-X G
K121606 · KLS-Martin L.P. · Jan 2013
BIOMET MICROFIXATION NEURO PLATING SYSTEM
K121624 · Biomet Microfixation · Oct 2012
PEEK CUSTOMIZED CRAIAL IMPLANT KIT
K121153 · Stryker · Sep 2012