Cleared Traditional

K131792 - SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY

K131792 is an FDA 510(k) clearance for SYNTHECEL DURA REPAIR, manufactured by Synthes, Inc.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K131792 · Synthes, Inc. · Neurology device
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Dec 2013
Decision
181d
Days
Class 2
Risk

K131792 is an FDA 510(k) clearance for the SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Synthes, Inc. (West Chester, US). The FDA issued a Cleared decision on December 16, 2013 after a review of 181 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - 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 Synthes, Inc. devices

FDA 510(k) Submission Details - K131792

510(k) Number K131792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2013
Decision Date December 16, 2013
Days to Decision 181 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
33d slower than avg
Panel avg: 148d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXQ Device Classification - Class 2, Special Controls

Product Code GXQ Dura Substitute
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5910
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 - GXQ Dura Substitute

All 33
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K131792.
Collagen Dural Regeneration Matrix
K150825 · Collagen Matrix, Inc. · Nov 2015
DURAFORM Dural Graft Implant
K152481 · Codman & Shurtleff, Inc. · Oct 2015
COLLAGEN DURA MEMBRANE
K141608 · Collagen Matrix, Inc. · Jan 2015
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K131015 · Cook Biotech, Inc. · Oct 2013
LYOPLANT ONLAY
K122791 · Aesculap, Inc. · Jun 2013
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
K092388 · Integra LifeSciences Corporation · Jan 2010