Cleared Traditional

K143661 - DirectInject

K143661 is an FDA 510(k) clearance for DirectInject, manufactured by Stryker. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K143661 · Stryker · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
253d
Days
Class 2
Risk

K143661 is an FDA 510(k) clearance for the DirectInject. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on September 2, 2015 after a review of 253 days - an extended review 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: 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 Stryker devices

FDA 510(k) Submission Details - K143661

510(k) Number K143661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2014
Decision Date September 02, 2015
Days to Decision 253 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
105d slower than avg
Panel avg: 148d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXP Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K143661.
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NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
K102018 · Synthes USA Products, LLC · Sep 2010
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
K071791 · Codman & Shurtleff, Inc. · Jul 2007
STRYKER INJECTABLE CEMENT
K060763 · Stryker · Sep 2006