SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES

K113251 · Synthes, Inc. · JEY · Dec 21, 2011 · Dental

Device Facts

• Record ID: K113251
• Device Name: SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
• Applicant: Synthes, Inc.
• Product Code: JEY · Dental
• Decision Date: Dec 21, 2011
• Decision: SESE
• Submission Type: Special
• 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

Anatomically contoured titanium or titanium alloy plates; designed to match body and angle regions of mandible; used with Synthes MatrixMANDIBLE screws of varying lengths/diameters; intended for single use; utilized in oral/maxillofacial surgery by surgeons; provides structural stabilization for mandibular fractures or reconstruction; improves patient outcomes by facilitating bone healing and structural integrity.

Clinical Evidence

Bench testing only; no clinical data required. Non-clinical dynamic and static testing demonstrated that the subject plates maintain a significantly longer fatigue life compared to the 2.5mm thick MatrixMANDIBLE plates under similar loading conditions.

Technological Characteristics

Materials: Titanium or titanium alloy. Form factor: Anatomically contoured plates for mandible body and angle. Energy source: None (mechanical). Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring oral, maxillofacial, 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 Preformed Reconstruction Plates (K091144)

Submission Summary (Full Text)

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SYNTHES
CMF

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## 510(k) Summary -- MatrixMANDIBLE Preformed Reconstruction Plates 2.2

| Name of Firm: | Synthes<br>1301 Goshen Parkway<br>West Chester, PA 19380 |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Elizabeth Kierzek<br>Associate Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | November 1, 2011 |
| Device Trade Name: | Synthes MatrixMANDIBLE Preformed Reconstruction<br>Plates |
| Device Generic Name: | Plate, bone |
| Product Code: | JEY |
| Regulation Number: | 872.4760 |
| Predicate Devices: | Synthes MatrixMANDIBLE Preformed<br>Reconstruction Plates (K091144) |
| Device Description: | The Synthes MatrixMANDIBLE Preformed<br>Reconstruction Plates are anatomically contoured to<br>match the body and angle regions of the mandible in<br>most patients. These plates are designed for use with<br>Synthes MatrixMANDIBLE screws that come in<br>multiple diameters and lengths to meet the anatomical<br>needs of the patient. System components are<br>manufactured in either titanium or titanium alloy and<br>are intended for single use only. |
| Intended Use /<br>Indications for Use: | The Synthes MatrixMANDIBLE Preformed<br>Reconstruction Plates are intended for use in oral and<br>maxillofacial surgery, trauma and reconstructive<br>surgery. This includes primary mandibular<br>reconstruction, comminuted fractures and temporary<br>bridging pending delayed secondary reconstruction,<br>including fractures of edentulous and/or atrophic<br>mandibles, as well as unstable fractures. |
| Comparison of the<br>technological<br>characteristics of the device<br>to the predicate device: | The design features, material, and indications for use of<br>the subject MatrixMANDIBLE Preformed<br>Reconstruction Plates are substantially equivalent to<br>the predicate device identified. Additionally, the safety<br>and effectiveness of this system is adequately<br>supported by documentation within this submission. |
| Performance Data<br>(Nonclinical and/or<br>Clinical): | Synthes conducted the following non-clinical testing:<br>dynamic and static testing. The conclusions drawn<br>from testing demonstrate that the MatrixMANDIBLE<br>Preformed Reconstruction Plates maintain a<br>significantly longer fatigue life compared to the 2.5mm<br>thick MatrixMANDIBLE plates when tested under<br>similar loading conditions. Clinical data was not<br>needed for this device. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and human well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Mr. Alan Haley Regulatory Affairs Specialist Synthes Incorporated 1302 Goshen Parkway · West Chester, Pennsylvania 19380

DEC 2 1 2011

Re: K113251

Trade/Device Name: Synthes MatrixMANDIBLE Preformed Reconstruction Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 12, 2011 Received: December 14, 2011

Dear Mr. Haley:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Mr. Haley

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 ( 1 c 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 /ucm 1 1 5809.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,

Wh for

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

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Indications for Use Statement 9

510(k) Number:

KITZƏZ (if known)

Device Name: Synthes MatrixMANDIBLE Preformed Reconstruction Plates

## Indications for Use:

The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in The Syllines MatrixMDDDD Frea and reconstructive surgery. This includes primary oral and maxmonolar bargery, adminuted fractures and temporary bridging pending delayed mandibular reconstruction, voluming fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

X Prescription Use (21 CFR 801 Subpart D) AND / OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruover

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

510(k) Number: K113251