Cleared Special

K040272 - SYNTHES (USA) CRANIOFACIAL PLATES

K040272 is an FDA 510(k) clearance for SYNTHES (USA) CRANIOFACIAL PLATES, manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 18-day FDA review.

K040272 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
18d
Days
Class 2
Risk

K040272 is an FDA 510(k) clearance for the SYNTHES (USA) CRANIOFACIAL PLATES. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on February 23, 2004 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory 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.

FDA 510(k) Submission Details - K040272

510(k) Number K040272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2004
Decision Date February 23, 2004
Days to Decision 18 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 128d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 293
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K040272.
LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
K030425 · Walter Lorenz Surgical, Inc. · May 2004
THE GNATHOMETER
K033092 · Ortho Gnathics, LLC · Apr 2004
OSTEOSORB TACK FIXATION SYSTEM
K030989 · Noviace Corporation · Apr 2004
ORTRAUTEK TRAUMA SYSTEM
K032520 · Tekka · Nov 2003
INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
K033194 · Inion , Ltd. · Oct 2003
ORTRAUTEK ORTHOGNATHIC SYSTEM
K031989 · Tekka · Oct 2003
K040272 · SYNTHES (USA) CRANIOFACIAL PLATES
Download PDF FDA Summary Synthes (Usa)