Cleared Traditional

K141385 - DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) (FDA 510(k) Clearance)

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

K141385 · Depuy Synthes Companies of Johnson & Johnson · Neurology device
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Mar 2015
Decision
304d
Days
Class 2
Risk

K141385 is an FDA 510(k) clearance for the DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS). Classified as Fastener, Plate, Cranioplasty (product code HBW), Class II - Special Controls.

Submitted by Depuy Synthes Companies of Johnson & Johnson (West Chester, US). The FDA issued a Cleared decision on March 27, 2015 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5360 - 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. Elevated predicate reliance profile. 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 K141385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2014
Decision Date March 27, 2015
Days to Decision 304 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
156d slower than avg
Panel avg: 148d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBW Fastener, Plate, Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5360
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.