Cleared Special

K113251 - SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES

K113251 is an FDA 510(k) clearance for SYNTHES MATRIXMANDIBLE PERFORMED RECONS..., manufactured by Synthes, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 48-day FDA review.

K113251 · Synthes, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
48d
Days
Class 2
Risk

K113251 is an FDA 510(k) clearance for the SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes, Inc. (West Chester, US). The FDA issued a Cleared decision on December 21, 2011 after a review of 48 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 - K113251

510(k) Number K113251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2011
Decision Date December 21, 2011
Days to Decision 48 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
80d faster than avg
Panel avg: 128d · This submission: 48d
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 290
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K113251.
LEFORTE SYSTEM BONE PLATE & SCREW
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BONE PLATE
K110926 · Biomaterials Korea, Inc. · Dec 2011
ARCHITEX SPACE MAINTENANCE SYSTEM
K110259 · Medtronic Sofamor Danek USA, Inc. · Apr 2011
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
K103136 · Materialise NV · Mar 2011
K113251 · SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
Download PDF FDA Summary Synthes, Inc.