Cleared Traditional

K143661 - DirectInject (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143661 · Stryker · Neurology device
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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.

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Submission Details

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
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.

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 42
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K143661.
Permatage Flowable, Settable Bone Paste
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MONTAGE-QS Settable, Resorbable Bone Putty
K231475 · Orthocon, Inc. · Oct 2023
MONTAGE Settable, Resorbable Bone Putty
K221933 · Orthocon, Inc. · Jan 2023