Cleared Traditional

K102018 - NORIAN REINFORCED

K102018 is the FDA 510(k) clearance for NORIAN REINFORCED by Synthes USA Products, LLC. It is a Class 2 Neurology device (product code GXP) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K102018 · Synthes USA Products, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
66d
Days
Class 2
Risk

K102018 is an FDA 510(k) clearance for the NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on September 23, 2010 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes USA Products, LLC devices

Submission Details

510(k) Number K102018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2010
Decision Date September 23, 2010
Days to Decision 66 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
82d faster than avg
Panel avg: 148d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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 - GXP Methyl Methacrylate For Cranioplasty

All 24
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K102018.
MONTAGE Settable, Resorbable Bone Putty
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DB-CMF
K182742 · Dimensional Bioceramics, LLC · Jun 2019
DirectInject
K143661 · Stryker · Sep 2015
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
K071791 · Codman & Shurtleff, Inc. · Jul 2007
STRYKER INJECTABLE CEMENT
K060763 · Stryker · Sep 2006
NORIAN CRS FAST SET PUTTY
K060443 · Synthes (Usa) · Apr 2006