SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES

K033065 · Synthes (Usa) · MQN · Oct 29, 2003 · Dental

Device Facts

• Record ID: K033065
• Device Name: SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
• Applicant: Synthes (Usa)
• Product Code: MQN · Dental
• Decision Date: Oct 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 2.0 mm Craniofacial Locking Plates are indicated for selective trauma of the midface and craniofacial skeleton; craniofacial surgery, reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Device Story

Synthes 2.0 mm Craniofacial Locking Plates are bone fixation devices used in craniofacial and orthognathic surgical procedures. The plates feature threaded holes designed to interface with 2.0 mm locking screws, 2.0 mm cortex screws, and 2.4 mm emergency screws. This locking screw/plate interface provides stable fixation of bone segments. The device is intended for use by surgeons in clinical settings to stabilize the midface and craniofacial skeleton during trauma repair or reconstructive surgery. The plates are constructed from CP Titanium.

Clinical Evidence

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

Technological Characteristics

Material: CP Titanium. Design: Bone fixation plates with threaded holes for locking screw interface. Compatibility: 2.0 mm Locking screws, 2.0 mm Cortex screws, 2.4 mm Emergency screws.

Indications for Use

Indicated for patients requiring fixation for selective trauma of the midface and craniofacial skeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla and chin.

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 2.0 mm Craniofacial Plates
• Synthes 2.0 mm Mandible Locking Plates

Submission Summary (Full Text)

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## OCT 2 9 2003

K033065

## 3. 510(k) Summary

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Bonnie J. Smith |
| Device name: | 2.0 mm Craniofacial Locking Plates |
| Classification: | Class II, §872,4760 - Plate, fixation, bone. |
| Intended use: | Synthes 2.0 mm Craniofacial Locking Plates are indicated for<br>selective trauma of the midface and craniofacial skeleton;<br>craniofacial surgery, reconstructive procedures; and selective<br>orthognathic surgery of the maxilla and chin. |
| Predicate device(s): | Synthes 2.0 mm Craniofacial Plates and Synthes 2.0 mm<br>Mandible Locking Plates |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes<br>2.0 mm Craniofacial Locking Plates are substantially equivalent<br>to the predicate devices. |
| Device description: | Synthes 2.0 mm Craniofacial Locking Plates provide a locking<br>screw/plate interface. The plates contain threaded holes which<br>allow the use of 2.0 mm Locking screws, 2.0 mm Cortex screws<br>and 2.4 mm Emergency screws. |
| Material: | CP Titanium |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three wavy lines above them. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2003

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K033065

Trade/Device Name: 2.0 mm Craniofacial Locking Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MON, JEY Dated: September 26, 2003 Received: September 29, 2003

Dear Ms. Smith:

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 vour 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. Smith

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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## Indications for Use Statement 2.

Page ____________ of _________________________________________________________________________________________________________________________________________________________

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510(k) Number (if known):

Device Name:

2.0 mm Craniofacial Locking Plates

K033065

Indications for Use:

Synthes 2.0 mm Craniofacial Locking Plates are indicated for selective trauma of the midface and craniofacial skeleton; craniofacial surgery, reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Prescription Use (Per 21 CFR 801.109) | X |
| | OR |
| | Over-The-Counter Use |
| (Division Sign-Off) | Rei Muly for MSR |
| | Division of Anesthesiology, General Hospital, Infection Control, Dental Devices |
| Premarket Notification 510(k) Synthes 2.0 mm Craniofacial Locking Plates 510(k) Number: | K033065 |

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