Cleared Traditional

K123633 - TRS CRANIAL BONE VOID FILLER(TRS C-BVF)

K123633 is an FDA 510(k) clearance for TRS CRANIAL BONE VOID FILLER(TRS C-BVF), manufactured by Tissue Regeneration Systems, Inc.. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K123633 · Tissue Regeneration Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K123633

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.

GXR Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K123633.
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AESCULAP PEEK CRANIOFIX
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MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K042986 · Synthes (Usa) · Nov 2004