Cleared Traditional

K041350 - SYNTHES (USA) CHRONOS

K041350 is an FDA 510(k) clearance for SYNTHES (USA) CHRONOS, manufactured by Synthes (Usa). The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 49-day FDA review.

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

FDA 510(k) Submission Details - K041350

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
Combination Product No
PCCP Authorized No
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.

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 39
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K041350.
VISIOPLAST ACRYLIC RESIN
K042414 · Tecres · Dec 2004
MIMIX MP BONE VOID FILLER
K043280 · Biomet, Inc. · Dec 2004
CALLOS CMF BONE VOID FILLER
K042072 · Skeletal Kinetics, LLC · Sep 2004
BONE CEMENT FOR CRANIOPLASTY
K040152 · Cardinalhealth · May 2004
BONESOURCE HAC FAST SETTING CEMENT
K032366 · Stryker Instruments · Oct 2003
CAP BONE SUBSTITUTE MATERIAL
K032307 · Etex Corp. · Oct 2003