Cleared Traditional

K083388 - SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM

K083388 is an FDA 510(k) clearance for SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K083388 · Synthes (Usa) · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2009
Decision
115d
Days
Class 2
Risk

K083388 is an FDA 510(k) clearance for the SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on March 12, 2009 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K083388

510(k) Number K083388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2008
Decision Date March 12, 2009
Days to Decision 115 days
Submission Type Traditional
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
12d faster than avg
Panel avg: 127d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K083388.
SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
K091233 · Synthes (Usa) · Dec 2009
LEFORTE SYSTEM BONE PLATE
K091679 · Jeil Medical Corporation · Oct 2009
SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
K091144 · Synthes (Usa) · Aug 2009
SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K082335 · Synthes (Usa) · Nov 2008
MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
K082757 · Bioplate, Inc. · Oct 2008
SONICWELD RX (RESORB-X)
K080862 · KLS-Martin L.P. · Jul 2008