SYNTHES CRANIOFACIAL PLATES

K021642 · Synthes (Usa) · JEY · Aug 14, 2002 · Dental

Device Facts

• Record ID: K021642
• Device Name: SYNTHES CRANIOFACIAL PLATES
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Aug 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Craniofacial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Device Story

Synthes Craniofacial Plates are titanium bone fixation plates used in craniofacial and midface trauma, reconstructive surgery, and orthognathic surgery of the maxilla and chin. The device provides mechanical stabilization of bone segments. It is intended for use by surgeons in a clinical or hospital setting. The plates are provided in various shapes and sizes to accommodate specific anatomical requirements of the craniofacial skeleton.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium bone fixation plates; various shapes and sizes; mechanical fixation device.

Indications for Use

Indicated for patients requiring fixation in selective trauma of the midface and craniofacial skeleton, craniofacial reconstructive surgery, 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.

Submission Summary (Full Text)

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AUG 1 4 2002

K021642

## 3. Summary of Safety and Effectiveness Information

| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull<br>[phone] ext. 7191 |
| Name of the Device | Synthes Craniofacial Plates |
| Device Classification(s) | Class II, §872.4760 - Plate, Fixation, Bone |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes<br>Craniofacial Plates to be substantially equivalent to other legally<br>marketed devices. |
| Device Description | The Synthes Craniofacial Plates are titanium plates in a variety of<br>shapes and sizes designed for various cranio-facial procedures. |
| Indications | The Synthes Craniofacial Plates are intended for use in selective<br>trauma of the midface and craniofacial skeleton; craniofacial surgery<br>reconstructive procedures; and selective orthognathic surgery of the<br>maxilla and chin |
| Material | Titanium |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three birds in flight, arranged in a row. The birds are facing to the left. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2002

Mr. Matthew M. Hull Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K021642

Trade/Device Name: Synthes Craniofacial Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: May 17, 2002 Received: May 20, 2002

Dear Mr. Hull

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.

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.

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Page 2 -- Mr. Hull

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]dditionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Patrici Cucinotta for

Timothy A. Ulatowski 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. Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

K021642

Synthes Craniofacial Plates

The Synthes Craniofacial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use レ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Suza Pena

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

510(k) Number:

Synthes(USA) Synthes Craniofacial Plates 510(k) CONFIDENTIAL