SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR

K043555 · Synthes (Usa) · MQN · Apr 12, 2005 · Dental

Device Facts

• Record ID: K043555
• Device Name: SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
• Applicant: Synthes (Usa)
• Product Code: MQN · Dental
• Decision Date: Apr 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congential deformity.

Device Story

The Synthes Alveolar Ridge Distractor is an extraosseous distraction device used for vertical bone lengthening of the mandible or maxilla. The device consists of a distractor body, a transport plate, a base plate, and a vector control mechanism. It is placed submucosally by a clinician; the base plate is fastened to the stationary bone segment and the transport plate is fastened to the mobile bone segment using 1.5 mm cortex screws. The device facilitates gradual bone distraction to address deficiencies in bone height caused by trauma, resorption, periodontal disease, tumor resection, or congenital deformity.

Clinical Evidence

Bench testing only.

Technological Characteristics

Extraosseous distraction device; includes distractor body, transport plate, base plate, and vector control mechanism. Fixation via 1.5 mm cortex screws. Mechanical operation.

Indications for Use

Indicated for patients requiring vertical bone lengthening of the alveolar ridge in the mandible or maxilla due to trauma, post-extraction resorption, periodontal disease, tumor resection, or congenital deformity.

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

• KLS Martin - Track 1.0 & 1.5mm System
• Lorenz Surgical, Inc - Lorenz Distraction System

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the Synthes logo and the date APR 12 2005. The Synthes logo is a circle with a stylized "S" inside. The word "SYNTHES" is written in bold, black letters next to the logo. The date is written in black letters to the right of the word "SYNTHES". A horizontal line is present below the logo and text.

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APR 1 2 2005

K043555

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| 3.0 | 510(k) Summary | Page 1 of 1 |
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| | Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
| | Device Name: | Synthes Alveolar Ridge Distractor |
| | Classification: | Class II, §872.4760 - Bone Plate |
| | Predicate Device: | KLS Martin - Track 1.0 & 1.5mm System<br>Lorenz Surgical, Inc - Lorenz Distraction System |
| | Device Description: | The Synthes Alveolar Ridge Distractor is an extraosseous<br>distraction device consisting of a distractor body, a transport plate,<br>a base plate, and a vector control mechanism. It is intended to be<br>placed submucosally, with the base plate fastened to the stationary<br>segment of the mandible or maxilla and the transport plate fastened<br>to the mobile bone segment. The plates are fixed to the bone using<br>1.5 mm cortex screws. |
| | Intended Use: | The Synthes Alveolar Distractor is intended for vertical bone<br>lengthening of the alveolar ridge in the mandible and the maxilla<br>where gradual bone distraction is required, including deficiency in<br>bone height as a result of trauma, resorption after dental extraction,<br>periodontal disease, tumor resection, and congential deformity. |
| | Substantial<br>Equivalence: | Documentation was provided which demonstrated the Synthes<br>Alveolar Ridge Distractor to be substantially equivalent to other<br>legally marketed devices.<br>The term "substantial equivalence" as used in this 510(k)<br>notification is limited to the definition of substantial equivalence<br>found in the Federal Food, Drug and Cosmetic Act, as amended<br>and as applied under 21CFR 807, Subpart E under which a device<br>can be marketed without premarket approval or reclassification. A<br>determination of substantial equivalency under this notification is<br>not intended to have any bearing whatsoever on the resolution of<br>patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence<br>herein shall be construed as an admission against interest under the<br>US Patent Laws or their application by the courts. |

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2005

Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K043555

Trade/Device Name: Synthes (USA) Alveolar Ridge Distractor Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: March 17, 2005 Received: March 18, 2005

Dear Ms. Anderson :

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 Eederal Register.

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Page 2 - ms. Anderson

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/industry/support/index.html.

Sincerely yours,

CluLs

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

510(k) Number (if known):

Device Name:

Synthes (USA) Alveolar Ridge Distractor_______________________________________________________________________________________________________________________________________

K0435555

Indications for Use:

The Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of:

- . Trauma
- Resorption after dental extraction .
- Periodontal disease .
- Tumor resection ◆
- Congenital deformity .

X Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div align="center">Senior</div> |
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| Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number | KA13555 |

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