SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES

K091144 · Synthes (Usa) · JEY · Aug 25, 2009 · Dental

Device Facts

• Record ID: K091144
• Device Name: SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Aug 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

Device Story

Synthes MatrixMANDIBLE Preformed Reconstruction Plates are anatomically contoured plates designed for mandible body and angle regions. Used in oral and maxillofacial surgery; trauma; reconstructive surgery. Plates are secured using Synthes MatrixMANDIBLE screws of varying lengths/diameters. Intended for single use. Provides structural stabilization for mandibular fractures and reconstruction. Operated by surgeons in clinical/OR settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium or titanium alloy. Form factor: Anatomically preformed plates for mandibular body and angle. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring oral and maxillofacial surgery, trauma, or reconstructive surgery, including primary mandibular reconstruction, comminuted fractures, temporary bridging for delayed secondary reconstruction, fractures of edentulous or atrophic mandibles, and unstable fractures.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Synthes MatrixMANDIBLE Plate and Screw System

Submission Summary (Full Text)

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AUG 2 5 2009

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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a circle with a design inside. To the right of the word is a circled R symbol. There is a horizontal line below the word.

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Kog 1144

| 3.0 | 510(k) Summary |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Page 1 of 1 |
| Sponsor: | Synthes<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| Contact: | Amnon Talmor<br>Synthes<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| Device Name: | Synthes MatrixMANDIBLE Preformed Reconstruction Plates |
| Classification: | Class II per 21 CFR §872.4760: Plate, Bone |
| Predicate Devices: | Synthes MatrixMANDIBLE Plate and Screw System |
| Device Description: | The subject of this 510(k) is the Synthes MatrixMANDIBLE<br>Preformed Reconstruction Plates. These plates are<br>anatomically contoured to match the body and angle regions of<br>the mandible in most patients. These plates are designed for<br>use with Synthes MatrixMANDIBLE screws that come in<br>multiple diameters and lengths to meet the anatomical needs of<br>the patient. System components are manufactured in either<br>titanium or titanium alloy and are intended for single use only. |
| Intended Use: | The Synthes MatrixMANDIBLE Preformed Reconstruction<br>Plates are intended for use in oral and maxillofacial surgery,<br>trauma and reconstructive surgery. This includes primary<br>mandibular reconstruction, comminuted fractures and temporary<br>bridging pending delayed secondary reconstruction, including<br>fractures of edentulous and/or atrophic mandibles, as well as<br>unstable fractures. |
| Substantial Equivalence: | Information presented supports substantial equivalence. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is in all caps and is arranged in a circular fashion to match the shape of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

## AUG 2 5 2009

Ms. Andrea M. Tasker CMF Regulatory Affairs Manager Synthes USA 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K091144

Trade/Device Name: Synthes MatrixMANDIBLE Preformed Reconstruction Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 12, 2009 Received: August 13, 2009

Dear Ms. Tasker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2- Ms. Tasker

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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Indications for Use 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Synthes MatrixMANDIBLE Preformed Reconstruction Plates Indications for Use: The Synthes MatrixMANDIBLE Preformed Reconstruction Plates

are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

Prescription Use × (Per 21 CFR 801.109)

2.0

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Reen Muly for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: