INTRAORAL MANDIBULAR DISTRACTION SYSTEM

K013618 · Osteomed Corp. · MQN · Aug 14, 2002 · Dental

Device Facts

• Record ID: K013618
• Device Name: INTRAORAL MANDIBULAR DISTRACTION SYSTEM
• Applicant: Osteomed Corp.
• Product Code: MQN · Dental
• Decision Date: Aug 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The OsteoMed Intraoral Mandibular Distraction System is intended for single patient use only.

Device Story

Subcutaneous bone distractor for mandibular distraction osteogenesis; features curved/straight bars activated by threaded wire; fixed to bone via 1.6mm/2.0mm screws. Operated by clinician using hex driver to advance threaded wire; provides distraction lengths up to 35mm. Used in clinical setting for single patient application. Device facilitates bone lengthening to treat conditions like micrognathia or hemifacial microsomia.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Subcutaneous bone distractor; available in curved/straight bars, right/left versions; 1.6mm/2.0mm bone screw fixation; threaded wire activation mechanism; max 35mm distraction length.

Indications for Use

Indicated for patients requiring mandibular bone lengthening due to conditions such as mandibular micrognathia or hemifacial microsomia.

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

• OsteoMed Intraoral Distraction System (K990944)
• Leibinger Vazquez-Diner Intraoral Distraction Device (K964649)
• Howmedica Guerrero-Bell Distractor (K972166)

Submission Summary (Full Text)

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AUG 1 4 2002

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# 510(k) Summary

| Device Proprietary Name: | OsteoMed Intraoral Mandibular<br>Distraction System |
|--------------------------|------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Intraoral Distractor |
| Classification Name: | MQN, External Mandibular<br>Fixator and/or Distractor |
| Name of Submitter: | OsteoMed Corporation<br>3750 Realty Road<br>Addison, Texas 75001<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | October 31, 2001 |

Summary:

This submission describes the OsteoMed Intraoral Mandibular Distraction System indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The OsteoMed Intraoral Mandibular Distraction System is intended for single patient use only.

The OsteoMed Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm/2.0mm bone screws. The distractor is available in two sizes and in right and left versions. The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 35mm.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the OsteoMed Intraoral Distraction System (K990944), Leibinger Vazquez-Diner Intraoral Distraction Device (K964649) and the Howmedica Guerrero-Bell Distractor (K972166).

Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Intraoral Mandibular Distraction System does not raise any new safety or effectiveness issues.

Image /page/0/Picture/11 description: The image shows the Marmon logo and the text "A member of The Marmon Group of companies". The logo is a stylized "M" with four vertical bars. The text is in a smaller font and is located to the right of the logo. The image is simple and clean, with a focus on the Marmon brand.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2002

Ms. Dawn T. Holdeman Regulatory Affairs & Document Control OsteoMed Corporation 3750 Realty Road Addison, Texas 75001-4311

Re: K013618

Trade/Device Name: Intraoral Mandibular Distraction System Regulation Number: Bone Plate Regulation Name: 872.4760 Regulatory Class: II Product Code: MQN Dated: June 4, 2002 Received: June 5, 2002

Dear Mr. Holdeman:

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 – Ms. Holdeman

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); v 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 (301) 594- 4613. 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.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Patricia Caccavellor

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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## OsteoMed "Indications for Use" Submission

510(k) Number: 4013618 _______________________________________________________________________________________________________________________________________________________

| Device Name: | Osteomed Intraoral Mandibular<br>Distraction System |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | Indicated for use as a mandibular bone<br>lengthener for patients diagnosed with<br>conditions where treatment includes<br>mandibular distraction osteogenesis.<br>These conditions may include<br>diagnoses such as mandibular<br>micrognathia or hemifacial microsomia.<br>The OsteoMed Intraoral Mandibular<br>Distraction System is intended for<br>single patient use only. |

Susan Roares

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

510(k) Number: K(1)3(1)8