Cleared Traditional

K091144 - SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES

K091144 is an FDA 510(k) clearance for SYNTHES MATRIXMANDIBLE PREFORMED RECONS..., 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 127-day FDA review.

K091144 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
127d
Days
Class 2
Risk

K091144 is an FDA 510(k) clearance for the SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES. 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 August 25, 2009 after a review of 127 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 - K091144

510(k) Number K091144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2009
Decision Date August 25, 2009
Days to Decision 127 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
At panel average
Panel avg: 127d · This submission: 127d
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 K091144.
MEDPOR FIXATION SYSTEM
K091807 · Porex Surgical, Inc. · Jun 2010
SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
K091233 · Synthes (Usa) · Dec 2009
LEFORTE SYSTEM BONE PLATE
K091679 · Jeil Medical Corporation · Oct 2009
SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
K083388 · Synthes (Usa) · Mar 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