Cleared Traditional

K113071 - SYNTHECEL DURA REPLACEMENT DEVICES

K113071 is an FDA 510(k) clearance for SYNTHECEL DURA REPLACEMENT DEVICES, manufactured by Synthes. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K113071 · Synthes · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
84d
Days
Class 2
Risk

K113071 is an FDA 510(k) clearance for the SYNTHECEL DURA REPLACEMENT DEVICES. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Synthes (West Chester, US). The FDA issued a Cleared decision on January 9, 2012 after a review of 84 days - a notably fast clearance 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: 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 devices

FDA 510(k) Submission Details - K113071

510(k) Number K113071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2011
Decision Date January 09, 2012
Days to Decision 84 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
64d faster than avg
Panel avg: 148d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00859508 Completed Interventional Industry-sponsored

Study of SyntheCelTM Dura Replacement to Other Dura Replacements

A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery

99
Patients (actual)
8
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Cranial Dura Repair
Study design Parallel
Eligibility All sexes · 18 Years+
Sponsor Synthes USA HQ, Inc. (industry)
Started 2006-02-01 → Primary completion 2009-01-01
Primary outcome
Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele
Secondary outcome
Modified Rankin Scale (Patient Function Assessment)
View full study on ClinicalTrials.gov

Regulatory Peers - GXQ Dura Substitute

All 41
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K113071.
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K131015 · Cook Biotech, Inc. · Oct 2013
LYOPLANT ONLAY
K122791 · Aesculap, Inc. · Jun 2013
DURAGEN SECURE DURAL REGNERATION MATRIX
K120600 · Integra Life Sciences · Jun 2012
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
K092388 · Integra LifeSciences Corporation · Jan 2010
DURAGEN XS DURAL REGENERATION MATRIX
K072207 · Integra Lifesciences Corp. · Aug 2007
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
K063117 · Medtronic Neurosurgery · Nov 2006