Cleared Traditional

K123633 - TRS CRANIAL BONE VOID FILLER(TRS C-BVF) (FDA 510(k) Clearance)

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

K123633 · Tissue Regeneration Systems, Inc. · Neurology device
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Aug 2013
Decision
266d
Days
Class 2
Risk

K123633 is an FDA 510(k) clearance for the TRS CRANIAL BONE VOID FILLER(TRS C-BVF). Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Tissue Regeneration Systems, Inc. (Kirkland, US). The FDA issued a Cleared decision on August 16, 2013 after a review of 266 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - 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 Tissue Regeneration Systems, Inc. devices

Submission Details

510(k) Number K123633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2012
Decision Date August 16, 2013
Days to Decision 266 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
118d slower than avg
Panel avg: 148d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
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 - GXR Cover, Burr Hole

All 28
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K123633.
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
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Absorbable Cranial Flap Fixation System
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K192162 · Neurovention, LLC · Mar 2020
OSSDSIGN Cranioplug
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