SYNTHES MANDIBLE EXTERNAL FIXATOR

K040169 · Synthes (Usa) · MQN · Apr 14, 2004 · Dental

Device Facts

• Record ID: K040169
• Device Name: SYNTHES MANDIBLE EXTERNAL FIXATOR
• Applicant: Synthes (Usa)
• Product Code: MQN · Dental
• Decision Date: Apr 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Device Story

Synthes Mandible External Fixator is a mechanical bone fixation system used for stabilizing maxillofacial fractures and defects. Components include adjustable MR-safe clamps, 4.0/2.5 Schanz screws, 2.5 mm K-wires, and 4.0 mm rods (titanium or carbon fiber). The device is applied by surgeons in a clinical setting to provide rigid fixation for bone healing. It functions as a structural support system to maintain bone alignment during the treatment of complex fractures, nonunions, or following surgical resections. The system is designed for use in the MR environment.

Clinical Evidence

Bench testing only.

Technological Characteristics

System components include adjustable MR-safe clamps, 4.0/2.5 Schanz screws, 2.5 mm K-wires, and 4.0 mm rods made of titanium or carbon fiber. The device is a mechanical fixation system; no energy source or software is utilized.

Indications for Use

Indicated for patients requiring stabilization and treatment of maxillofacial fractures, including severe open mandibular fractures, highly comminuted closed fractures, nonunions, delayed unions, infection-associated fractures, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

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 Mini External Fixator

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. To the right of the word is a circled "R" symbol, indicating a registered trademark.

| 3.0 | 510(k) Summary | APR 1 4 2004 | Page 1 of 1 |
|-----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] | |
| | Device Name: | Synthes Mandible External Fixator | |
| | Classification: | Class II, 21 CFR §888.3030 - Single/multiple component bone fixation<br>appliances and accessories. | |
| | Predicate Devices: | Synthes Mini External Fixator | |
| | Device Description: | Synthes Mandible External Fixator consists of the following<br>components: An Adjustable Clamp - MR Safe; 4.0/2.5 Schanz Screws;<br>2.5 mm K-wires; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon<br>Fiber Rods. The components of this system are designed for use in the<br>MR environment. The rods and Schanz Screws are available in various<br>lengths. | |
| | Intended Use: | Synthes Mandible External Fixator is intended to stabilize and provide<br>treatment for fractures of the maxillofacial area, including severe open<br>mandibular fractures, highly comminuted closed fractures, nonunions<br>and delayed unions (especially associated with infection), fractures<br>associated with infections, tumor resections, facial deformity<br>corrections, gunshot wounds, pan facial fractures, burn maintenance,<br>and bone grafting defects. | |
| | Substantial<br>Equivalence: | The new device is considered to be substantially equivalent to the<br>predicate device based on mechanical test results. | |

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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2004

Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301-0800

Re: K040169

Trade/Device Name: Synthes Mandible External Fixator Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: January 23, 2004 Received: January 26, 2004

Dear Ms. Musgnung:

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. Musgnung

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/dsma/dsmamain.html

Sincerely yours.

Ques

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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## 2.0 Indications for Use Statement

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Cynthia Meredith, Extension Educator

1040169

Device Name:

Synthes Mandible External Fixator

Indications:

Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, turnor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">✓</div> | OR | Over-the-Counter Use | |
|------------------------------------------|-----------------------------------------|----|----------------------|--|
|------------------------------------------|-----------------------------------------|----|----------------------|--|

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

| 510(k) Number: | -4/13/04 K040169 |
|----------------|------------------|
|----------------|------------------|

CONFIDENTIAL

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