Cleared Special

TRACERS BONE CEMENT OPACIFIER (K023445) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K023445 · Parallax Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
147d
Days
Class 2
Risk

K023445 is an FDA 510(k) clearance for the TRACERS BONE CEMENT OPACIFIER. Classified as Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty (product code MYU), Class II - Special Controls.

Submitted by Parallax Medical, Inc. (Scotts Valley, US). The FDA issued a Cleared decision on March 11, 2003 after a review of 147 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Parallax Medical, Inc. devices

Submission Details

510(k) Number K023445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date March 11, 2003
Days to Decision 147 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 148d · This submission: 147d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MYU Accessory, Barium Sulfate, 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.