Cleared Special

K043297 - MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM

K043297 is an FDA 510(k) clearance for MEDICON 2.4 MANDIBULAR RECONSTRUCTION P..., manufactured by Medicon EG. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 86-day FDA review.

K043297 · Medicon EG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
86d
Days
Class 2
Risk

K043297 is an FDA 510(k) clearance for the MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Medicon EG (Amsterdam, NL). The FDA issued a Cleared decision on February 23, 2005 after a review of 86 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 - K043297

510(k) Number K043297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2004
Decision Date February 23, 2005
Days to Decision 86 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
42d faster than avg
Panel avg: 128d · This submission: 86d
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 283
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K043297.
SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
K050608 · Synthes (Usa) · May 2005
MODUS TITANIUM OSTEOSYNTHESIS SYSTEM
K050934 · Medartis, Inc. · May 2005
SYNTHES RAPID RESORBABLE TACK SYSTEM
K050204 · Synthes (Usa) · Mar 2005
MODIFICATION TO SYNTHES CRANIAL PLATES
K042987 · Synthes (Usa) · Nov 2004
SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
K042365 · Synthes (Usa) · Nov 2004
BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS
K042517 · Linvatec Biomaterials, Ltd. · Oct 2004