Cleared Traditional

K032366 - BONESOURCE HAC FAST SETTING CEMENT

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

K032366 · Stryker Instruments · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K032366

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.

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 38
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K032366.
CALLOS CMF BONE VOID FILLER
K042072 · Skeletal Kinetics, LLC · Sep 2004
SYNTHES (USA) CHRONOS
K041350 · Synthes (Usa) · Jul 2004
BONE CEMENT FOR CRANIOPLASTY
K040152 · Cardinalhealth · May 2004
CAP BONE SUBSTITUTE MATERIAL
K032307 · Etex Corp. · Oct 2003
BIOMET CRANIOFACIAL ACRYLIC CEMENT
K011399 · Biomet, Inc. · May 2003
QUICKSET MIMIX BONE VOID FILLER
K023718 · Walter Lorenz Surgical, Inc. · Dec 2002