Cleared Special

TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (K033230) - FDA 510(k) Clearance

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

K033230 · Parallax Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
67d
Days
Class 2
Risk

K033230 is an FDA 510(k) clearance for the TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA. 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 December 12, 2003 after a review of 67 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 K033230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2003
Decision Date December 12, 2003
Days to Decision 67 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
81d faster than avg
Panel avg: 148d · This submission: 67d
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.