OSTEOMED INTRAORAL DISTRACTION SYSTEM

K990944 · Osteomed Corp. · MQN · Jun 16, 1999 · Dental

Device Facts

• Record ID: K990944
• Device Name: OSTEOMED INTRAORAL DISTRACTION SYSTEM
• Applicant: Osteomed Corp.
• Product Code: MQN · Dental
• Decision Date: Jun 16, 1999
• 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.

Device Story

OsteoMed Intraoral Distraction System is a subcutaneous bone distractor used for mandibular bone lengthening. Device consists of curved or straight bars fixed to bone via 1.6mm bone screws. Activation occurs via a threaded wire manipulated by a hex driver; provides distraction lengths up to 25mm. Used in clinical settings for patients requiring mandibular distraction osteogenesis. Physician operates device to gradually lengthen bone; output is mechanical distraction of the mandible. Benefits include correction of mandibular deficiencies like micrognathia or hemifacial microsomia.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarities to predicate devices.

Technological Characteristics

Subcutaneous bone distractor; features curved/straight bars; 1.6mm bone screw fixation; threaded wire activation mechanism; manual operation via hex driver; distraction capacity up to 25mm.

Indications for Use

Indicated for patients diagnosed with conditions requiring mandibular distraction osteogenesis, including 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

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

Submission Summary (Full Text)

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K9909444

| Image: OSTEOMED CORPORATION logo | | |
|--------------------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------|
| | 510(k) Summary | |
| | Device Proprietary Name: | OsteoMed Intraoral Distraction<br>System |
| | Device Common Name: | Intraoral Distractor |
| specialized<br>orthopaedic<br>products | Classification Name: | MQN, External Mandibular<br>Fixator and/or Distractor |
| craniofacial<br>reconstruction<br>products | Name of Submitter: | OsteoMed Corporation<br>3750 Realty Road<br>Addison, Texas 75001<br>Phone: [phone]<br>Fax: [phone] |
| new product<br>development | Contact Person: | Dawn T. Holdeman |
| | Date Prepared: | March 19, 1999 |
| | Summary: | |

This submission describes the OsteoMed Intraoral Distraction System indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions mav include diagnoses such as mandibular micrognathia or hemifacial microsomia.

The OsteoMed Intraoral 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 bone screws. The distractor is available in right and left versions: The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 25mm.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the 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 Distraction System does not raise any new safety or effectiveness issues.

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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 human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or clothing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 1999

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

Re : K990944 OsteoMed Intraoral Distraction System Trade Name: Regulatory Class: II Product Code: MON Dated: March 19, 1999 Received: March 22, 1999

Dear Ms. Holdeman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Holdeman

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Osteomed Intraoral

Indications For Use:

Indicated for use as a mandibular bone Indicated for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rosiner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription Use (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)