Cleared Traditional

K212943 - SyntheCel Dura Repair

K212943 is an FDA 510(k) clearance for SyntheCel Dura Repair, manufactured by Synthes USA Products, LLC. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K212943 · Synthes USA Products, LLC · Neurology device
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Jan 2022
Decision
135d
Days
Class 2
Risk

K212943 is an FDA 510(k) clearance for the SyntheCel Dura Repair. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on January 28, 2022 after a review of 135 days - within the typical 510(k) review window.

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 USA Products, LLC devices

FDA 510(k) Submission Details - K212943

510(k) Number K212943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2021
Decision Date January 28, 2022
Days to Decision 135 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
13d faster than avg
Panel avg: 148d · This submission: 135d
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 41
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K212943.
Collagen Dura Regeneration Membrane - Repair
K251191 · Collagen Matrix, Inc. · Nov 2025
Helios Dura Regeneration Matrix
K250420 · Helios Biomedical, Inc. · May 2025
ArtiFascia
K223445 · Nurami Medical , Ltd. · Aug 2023
XenoSure Dura Biologic Patch
K183513 · LeMaitre Vascular, Inc. · Jun 2019
Cerafix Dura Substitute
K172603 · Acera Surgical, Inc. · Nov 2017
DuraGen Secure Dural Regeneration Matrix
K163456 · Integra LifeSciences Corporation · Jan 2017