Cleared Traditional

K040864 - CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM

K040864 is an FDA 510(k) clearance for CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP..., manufactured by Aesculap. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K040864 · Aesculap · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
76d
Days
Class 2
Risk

K040864 is an FDA 510(k) clearance for the CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Aesculap (Center Valley, US). The FDA issued a Cleared decision on June 17, 2004 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aesculap devices

FDA 510(k) Submission Details - K040864

510(k) Number K040864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2004
Decision Date June 17, 2004
Days to Decision 76 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
72d faster than avg
Panel avg: 148d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
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 - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 45
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K040864.
PATIENT CONTOURED MESH (PCM)
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K031034 · Walter Lorenz Surgical, Inc. · May 2003
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K022277 · Osteomed Corp. · Apr 2003
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K030378 · Stryker Instruments · Mar 2003