SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES

K091233 · Synthes (Usa) · JEY · Dec 11, 2009 · Dental

Device Facts

• Record ID: K091233
• Device Name: SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Dec 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.

Device Story

Synthes MatrixMANDIBLE Subcondylar Plates are orthopedic bone plates designed for internal fixation of mandibular fractures. Plates are contoured to match subcondylar anatomy and used with compatible Synthes MatrixMANDIBLE screws. Device is intended for single use in oral, maxillofacial, trauma, and reconstructive surgical procedures. Operated by surgeons in clinical settings to stabilize bone segments, facilitating healing and restoring mandibular function.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Bone plates manufactured from titanium or titanium alloy. Designed for single use. Mechanical fixation via screws. No software or electronic components.

Indications for Use

Indicated for patients requiring oral, maxillofacial, trauma, or reconstructive surgery for fractures of the subcondylar or condylar basis regions of the mandible.

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
• MODUS® Titanium Osteosynthesis System

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. The circular symbol appears to be a stylized representation of a medical device or implant. A small circle with an R inside is located at the top right of the word "SYNTHES".

3.0

DEC 1 1 2009

1091233

ら

510(k) Summary Page _________________________________________________________________________________________________________________________________________________________________________ Sponsor: Synthes 1301 Goshen Parkway West Chester, PA 19380 Contact: Contact: Andrea M. Tasker [e-mail] [phone] Device Name: Synthes MatrixMANDIBLE Subcondylar Plates Classification: Class 11, 21 CFR §872.4760, Bone plate Predicate Synthes MatrixMANDIBLE Plate and Screw System Devices: MODUS® Titanium Osteosynthesis System The Synthes MatrixMANDIBLE Subcondylar Plates are designed Device Description: specifically to match the anatomy of the subcondylar region of the mandible. These plates are designed for use with Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only. Intended Use: The Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible. Substantial Information presented supports substantial equivalence. 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 image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

## DEC 1 1 2009

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

Re: K091233

Trade/Device Name: Synthes MatrixMANDIBLE Subcondylar Plates Regulation Number: 21CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 23, 2009 Received: November 25, 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 vours.

Susan Rinner

Anthony D. Watson, BS, MS, MBA 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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SYNTHES®

2.0 Indications for Use

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------------------------|
| 510(k) Number (if known): | K091233 |
| Device Name: | Synthes MatrixMANDIBLE Subcondylar Plates |

INDICATIONS FOR USE:

The Synthes MatrixMANDIBLE Subcondylar Plates are intended for
oral, maxillofacial surgery; trauma and reconstructive surgery,
specifically for fractures of the subcondylar region of the mandible and
fractures of the condylar basis region of the mandible.

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------------------|-------------------------|
| Prescription Use (Per 21 CFR 801.109) | X |

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

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

510(k) Number: K091232