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MatrixWave MMF System

by Synthes (USA) Products, LLC 510(k)

Active United States

510(k) K141165

Overview

The MatrixWave MMF System is a bone-borne maxillomandibular fixation system. It consists of wave-shaped plates made from commercially pure titanium that are attached to the mandible and maxilla with self-drilling locking screws made from titanium alloy (Ti-6Al-7Nb).

The system is used to bring the dental arches into occlusion by wiring around the plate hooks and/or accessible screw heads. It is supplied as a non-sterile, reusable device intended for use in dental and maxillofacial surgical settings. The device received FDA 510(k) clearance (K141165) on October 17, 2014, and is classified as a Class II medical device under regulation number 872.4760 with product code JEY.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141165 Date17 Oct 2014ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the MatrixWave MMF System used for?

    The MatrixWave MMF System is a bone-bone fixation system used to bring dental arches into occlusion by wiring around plate hooks and/or accessible screw heads during dental and maxillofacial surgical procedures.

  • Is the MatrixWave MMF System sterile and single-use?

    The MatrixWave MMF System is supplied as a non-sterile, reusable device intended for use in dental and maxillofacial surgical settings. It requires proper sterilization before each use according to hospital protocols.

  • What materials are used in the MatrixWave MMF System?

    The system consists of wave-shaped plates made from commercially pure titanium and self-drilling locking screws made from titanium alloy (Ti-6Al-7Nb), ensuring biocompatibility and durability for surgical applications.

  • What is the regulatory status of the MatrixWave MMF System?

    The MatrixWave MMF System received FDA 510(k) clearance (K141165) on October 17, 2014, and is classified as a Class II medical device under regulation number 872.4760 with product code JEY.