Cleared Special

K023718 - QUICKSET MIMIX BONE VOID FILLER

K023718 is an FDA 510(k) clearance for QUICKSET MIMIX BONE VOID FILLER, manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Neurology device with product code GXP cleared through the Special 510(k) pathway after a 29-day FDA review.

K023718 · Walter Lorenz Surgical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
29d
Days
Class 2
Risk

K023718 is an FDA 510(k) clearance for the QUICKSET MIMIX BONE VOID FILLER. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 4, 2002 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K023718

510(k) Number K023718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2002
Decision Date December 04, 2002
Days to Decision 29 days
Submission Type Special
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
120d faster than avg
Panel avg: 149d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

GXP Device Classification - Class 2, Special Controls

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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 - GXP Methyl Methacrylate For Cranioplasty

All 44
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K023718.
CAP BONE SUBSTITUTE MATERIAL
K032307 · Etex Corp. · Oct 2003
BIOMET CRANIOFACIAL ACRYLIC CEMENT
K011399 · Biomet, Inc. · May 2003
CONCERT CRANIOPLAST
K023575 · Immedica, Inc. · Jan 2003
BONESOURCE HAC
K021440 · Stryker Instruments · Aug 2002
FAST SET PUTTY
K012589 · Synthes (Usa) · Feb 2002
DRG QUICKMIX
K011736 · Doctor'S Research Group, Inc. · Jan 2002
K023718 · QUICKSET MIMIX BONE VOID FILLER
Download PDF FDA Summary Walter Lorenz Surgica…