Cleared Traditional

K041350 - SYNTHES (USA) CHRONOS (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041350 · Synthes (Usa) · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
49d
Days
Class 2
Risk

K041350 is an FDA 510(k) clearance for the SYNTHES (USA) CHRONOS. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on July 8, 2004 after a review of 49 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. 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 Synthes (Usa) devices

Submission Details

510(k) Number K041350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2004
Decision Date July 08, 2004
Days to Decision 49 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
99d faster than avg
Panel avg: 148d · This submission: 49d
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 42
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K041350.
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MONTAGE Settable, Resorbable Bone Putty
K221933 · Orthocon, Inc. · Jan 2023