Cleared Traditional

K032307 - CAP BONE SUBSTITUTE MATERIAL

K032307 is an FDA 510(k) clearance for CAP BONE SUBSTITUTE MATERIAL, manufactured by Etex Corp.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K032307 · Etex Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
91d
Days
Class 2
Risk

K032307 is an FDA 510(k) clearance for the CAP BONE SUBSTITUTE MATERIAL. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Etex Corp. (Cambridge, US). The FDA issued a Cleared decision on October 24, 2003 after a review of 91 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 Etex Corp. devices

FDA 510(k) Submission Details - K032307

510(k) Number K032307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2003
Decision Date October 24, 2003
Days to Decision 91 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
57d faster than avg
Panel avg: 148d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 27
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K032307.
SYNTHES (USA) CHRONOS
K041350 · Synthes (Usa) · Jul 2004
BONE CEMENT FOR CRANIOPLASTY
K040152 · Cardinalhealth · May 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
BONESOURCE HAC
K021440 · Stryker Instruments · Aug 2002