Cleared Traditional

K032366 - BONESOURCE HAC FAST SETTING CEMENT

K032366 is the FDA 510(k) clearance for BONESOURCE HAC FAST SETTING CEMENT by Stryker Instruments. It is a Class 2 Neurology device (product code GXP) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K032366 · Stryker Instruments · Neurology device
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Oct 2003
Decision
90d
Days
Class 2
Risk

K032366 is an FDA 510(k) clearance for the BONESOURCE HAC FAST SETTING CEMENT. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 90 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 Stryker Instruments devices

Submission Details

510(k) Number K032366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2003
Decision Date October 30, 2003
Days to Decision 90 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 24
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K032366.
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
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