SYNTHES (USA) CRANIOFACIAL PLATES

K040272 · Synthes (Usa) · JEY · Feb 23, 2004 · Dental

Device Facts

• Record ID: K040272
• Device Name: SYNTHES (USA) CRANIOFACIAL PLATES
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Feb 23, 2004
• Decision: SESE
• Submission Type: Special
• 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 metallic bone plates designed for internal fixation in craniofacial and midfacial surgery. The plates feature a low-profile design and are customizable, allowing surgeons to cut or trim them to match specific patient anatomy. They are used in conjunction with 2.0 mm self-tapping or self-drilling bone screws and 2.4 mm emergency screws. The device is intended for use by surgeons in clinical settings to stabilize bone segments during reconstructive or orthognathic procedures, facilitating bone healing and structural restoration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparisons.

Technological Characteristics

Metallic bone plates with low-profile design; compatible with 2.0 mm self-tapping/self-drilling screws and 2.4 mm emergency screws; intended for surgical implantation.

Indications for Use

Indicated for patients requiring fixation in selective trauma of the midfacial 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 Sagittal Split Plate

Submission Summary (Full Text)

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FEB 2 3 2004

# 0272

### Summary of Safety and Effectiveness Information [510 Summary] 3.0

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Lisa M. Boyle |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Craniofacial Plates |
| CLASSIFICATION: | Class II , 21 CFR 872.4760: Bone Plate |
| PREDICATE DEVICE: | Synthes Sagittal Split Plate |
| DEVICE DESCRIPTION: | The Synthes Double Adaption Plate can be cut or trimmed to the desired<br>length to accommodate various fractures and meet the anatomical need of<br>the patient. The plate has a low plate / screw head profile, uses 2.0 mm<br>self-tapping or self-drilling bone screws and 2.4 mm emergency screws. |
| INTENDED USE: | The Synthes Craniofacial Plates are intended for use in selective trauma of<br>the midface and craniofacial skeleton; craniofacial surgery; reconstructive<br>procedures; and selective orthognathic surgery of the maxilla and chin. |
| SUBSTANTIAL<br>EQUIVALENCE: | Documentation is provided which demonstrates that the Synthes<br>CRANIOFACIAL Plates are substantially equivalent to other legally<br>marketed Synthes devices. |

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 2 3 2004

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA), Incorporated 1690 Russell Road Paoli, Pennsylvania 19301

Re: K040272

Trade/Device Name: Synthes (USA) Craniofacial Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bonc Plate Regulatory Class: II Product Code: JEY Dated: February 4, 2004 Received: February 5, 2004

Dear Ms. Boyle:

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. Boyle

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. or the Flor of any I outh all the Act's requirements, including, but not limited to: registration 1 od intelse comp?) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } and ifsting (21 CF ret 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) Finis letter will anon you to begal finding of substantial equivalence of your device to a premarketed 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), n you deette opber of Compliance at (301) 594-. 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 Inter 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,

Carls

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 2.0

| 510(k) Number (if known): | K040272 |
|---------------------------|-----------------------------------|
| Device Name: | Synthes (USA) Craniofacial Plates |

Indications:

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

Susan Runne

(Division Louis-U (Division of Anestin Looky) General Hospital, Infection Control. Deptai Lrevioes

510(k) Number K040272

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

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## Concurrence of CDRH, Office of Device Evaluation (ODE)