Cleared Traditional

K141165 - MATRIXWAVE MMF SYSTEM

K141165 is an FDA 510(k) clearance for MATRIXWAVE MMF SYSTEM, manufactured by Synthes USA Products, LLC. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K141165 · Synthes USA Products, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
164d
Days
Class 2
Risk

K141165 is an FDA 510(k) clearance for the MATRIXWAVE MMF SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on October 17, 2014 after a review of 164 days - an extended review cycle.

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 Products, LLC devices

FDA 510(k) Submission Details - K141165

510(k) Number K141165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2014
Decision Date October 17, 2014
Days to Decision 164 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
37d slower than avg
Panel avg: 127d · This submission: 164d
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 K141165.
OPTIMUS CMF SYSTEM
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K141764 · Impladent , Ltd. · Dec 2014
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
K133461 · Stryker · Aug 2014
RXG DISTRACTION SYSTEM
K133304 · KLS-Martin L.P. · May 2014
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
K121235 · Stryker · Jan 2014