THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM

K063790 · Synthes (Usa) · JEY · Apr 16, 2007 · Dental

Device Facts

• Record ID: K063790
• Device Name: THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Apr 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

Device Story

MatrixMANDIBLE Plate and Screw System; mandibular fixation system. Components include small, medium, large plates; self-tapping cortex screws; locking screws. Plates accept all system screws; various shapes/thicknesses. Manufactured from CP titanium and titanium alloy. Used in oral, maxillofacial, trauma, reconstructive, and orthognathic surgery. Surgeon-operated; provides rigid fixation of bone segments to facilitate healing/reconstruction.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Materials: CP titanium and titanium alloy. Components: Plates (small, medium, large) and screws (self-tapping cortex and locking). Design: Universal plate-screw compatibility. Mechanical fixation.

Indications for Use

Indicated for patients undergoing oral, maxillofacial, trauma, reconstructive, or orthognathic surgery for dentofacial deformities.

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 2.4 mm Universal Locking Plate System
• Synthes 2.0 Locking Plate System
• Synthes Mandibular Modular Fixation System
• Stryker Leibinger NewGen System

Submission Summary (Full Text)

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K663790

| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| | Contact: | APR 16 2007<br>Deborah L Jackson, RAC<br>Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| | Device Name: | The Synthes MatrixMANDIBLE Plate and Screw System |
| | Classification: | 21 CFR 872.4760: Bone plate |
| | Predicate Devices: | Synthes 2.4 mm Universal Locking Plate System<br>Synthes 2.0 Locking Plate System<br>Synthes Mandibular Modular Fixation System<br>Stryker Leibinger NewGen System |
| | Device Description: | The Synthes MatrixMANDIBLE Plate and Screw System is the<br>next generation of Synthes (USA) fixation systems for the<br>mandible. The system incorporates small, medium, and large<br>plates designed so that all plates accept all system screws. The<br>plates are available in various shapes and thicknesses, and accept<br>self-tapping cortex and locking screws.<br>The implants are<br>manufactured from CP titanium and titanium alloy. |
| | Intended Use: | The Synthes MatrixMANDIBLE Plate and Screw System is<br>intended for oral, maxillofacial surgery; trauma; reconstructive<br>surgery; and orthognathic surgery (surgical correction of<br>dentofacial deformities). |
| | Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Deborah L. Jackson Regulatory Affairs Specialist Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380

APR 16 2007

Re: K063790

Trade/Device Name: The Synthes MatrixMANDIBLE Plate and Screw System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 30, 2007 Received: April 2, 2007

Dear Ms. Jackson:

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 such 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. Jackson

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Snyte Y. Michael Omd.

Chiu Lin, Ph.D. 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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Page 1 of

2.0 Indications for Use

| 510(k) Number (if known): | K063790 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | The Synthes MatrixMANDIBLE Plate and Screw System |
| Indications for Use: | The Synthes MatrixMANDIBLE Plate and Screw System is<br>intended for oral, maxillofacial surgery; trauma; reconstructive<br>surgery; and orthognathic surgery (surgical correction of<br>dentofacial deformities). |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR Over-The-Counter Use (Per 21 CFR 801.109) (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)

Susan Russo

Son of Anactherintogy, General Hospital, Jon Control, Deman Devices

) Number: KD63790