SYNTHES MIDFACE DISTRACTOR

K022005 · Synthes (Usa) · JEY · Sep 3, 2002 · Dental

Device Facts

• Record ID: K022005
• Device Name: SYNTHES MIDFACE DISTRACTOR
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Sep 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as syndromic craniosynostosis and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones.

Device Story

Synthes Midface Distractor is a craniofacial distraction device; consists of two telescoping components with attached footplates. Device placed subcutaneously; anterior footplate fastened to lateral orbital rim/maxilla; posterior footplate fastened to temporal cranium. Fixed to bone via 1.5 mm or 2.0 mm Cortex screws. Used by surgeons for temporary stabilization and gradual lengthening of cranial or midfacial bones in patients undergoing reconstructive osteotomy. Provides mechanical distraction to facilitate bone segment advancement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium alloy, titanium, chromium cobalt, silicone. Design: Two telescoping components with footplates. Fixation: 1.5 mm or 2.0 mm Cortex screws. Class II bone plate (21 CFR 872.4760).

Indications for Use

Indicated for adult and pediatric patients requiring reconstructive osteotomy and segment advancement for cranial or midface conditions, including syndromic craniosynostosis and midfacial retrusion.

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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#### 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 Midface Distractor |
| Device Classification | Class II, §872.4760 - Bone Plate |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes<br>Midface Distractor to be substantially equivalent to other legally<br>marketed devices. |
| Device Description | The Synthes Midface Distractor is a craniofacial distraction device<br>consisting of two telescoping components with attached footplates.<br>The device is intended to be placed subcutaneously, with an anterior<br>footplate fastened to the lateral orbital rim, extending down to the<br>maxilla and spanning the zygomaticomaxillary suture; and a posterior<br>footplate fastened to the temporal region of the cranium. The plates<br>are fixed to the bone through unthreaded screw holes using 1.5 mm or<br>2.0 mm Cortex screws. |
| Indications | For use in adult and pediatric populations for the treatment of cranial<br>or midface conditions for which reconstructive osteotomy and<br>segment advancement are indicated. This includes conditions such as<br>syndromic craniosynostosis and midfacial retrusion. The device is<br>intended to provide temporary stabilization and gradual lengthening of<br>the cranial or midfacial bones. |
| Materials | Titanium Alloy, Titanium, Chromium Cobalt, Silicone |

Synthes(USA) ﮨ Synthes Midface Distractor 510(k)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of an eagle with three lines extending from its head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2002

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

Re: K022005

Trade/Device Name: Synthes Midface Distractor Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 17, 2002 Received: June 19, 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]. Additionally, 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,

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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K022005

#### Indications for Use Statement 2.

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510(k) Number (if known):

Device Name:

Indications for Use:

## Synthes Midface Distractor

The Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as syndromic craniosynostosis and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Sura Kumar

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

Synthes(USA) Synthes Midface Distractor 510(k)

510(k) Number.