Cleared Traditional

K040152 - BONE CEMENT FOR CRANIOPLASTY

K040152 is the FDA 510(k) clearance for BONE CEMENT FOR CRANIOPLASTY by Cardinalhealth. It is a Class 2 Neurology device (product code GXP) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K040152 · Cardinalhealth · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
117d
Days
Class 2
Risk

K040152 is an FDA 510(k) clearance for the BONE CEMENT FOR CRANIOPLASTY. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on May 19, 2004 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - 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 Cardinalhealth devices

Submission Details

510(k) Number K040152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2004
Decision Date May 19, 2004
Days to Decision 117 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
31d faster than avg
Panel avg: 148d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 25
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K040152.
BONE SOURCE HAC RAPID SETTING CEMENT
K043334 · Stryker Instruments · Feb 2005
MIMIX MP BONE VOID FILLER
K043280 · Biomet, Inc. · Dec 2004
SYNTHES (USA) CHRONOS
K041350 · Synthes (Usa) · Jul 2004
BONESOURCE HAC FAST SETTING CEMENT
K032366 · Stryker Instruments · Oct 2003
BIOMET CRANIOFACIAL ACRYLIC CEMENT
K011399 · Biomet, Inc. · May 2003
QUICKSET MIMIX BONE VOID FILLER
K023718 · Walter Lorenz Surgical, Inc. · Dec 2002