OSTEOMED ALVEOLAR DISTRACTION SYSTEM

K030790 · Osteomed LP · MQN · Sep 10, 2003 · Dental

Device Facts

• Record ID: K030790
• Device Name: OSTEOMED ALVEOLAR DISTRACTION SYSTEM
• Applicant: Osteomed LP
• Product Code: MQN · Dental
• Decision Date: Sep 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use in patients who have totally or partially edentulous mandible or maxilla or small craniofacial bone deficiencies and need an increase in bone height and mass by means of distraction osteogenesis. These patients include those who have traumatic defects, periodontal disease or birth abnormality. The distractor is designed to provide temporary stabilization and gradual expansion across an osteotomy in the mandibular bone or maxillary bone and thereby increasing the height of the adjacent Alveolar ridge. This device is intended to be removed after consolidation of the callus and prior to final prosthetic reconstruction. The OsteoMed Alveolar Distraction System is intended for single patient use only.

Device Story

Intraoral distraction osteogenesis system; provides temporary stabilization and gradual expansion across mandibular or maxillary osteotomies. Components: two bone plates, threaded rod, activation instrument. Plates attach to bone via screws; activation instrument turns threaded rod to distract osteotomized segment. Distraction length up to 20mm. Used in clinical setting by surgeons to increase alveolar ridge height. Device removed after callus consolidation, prior to final prosthetic reconstruction. Single patient use.

Clinical Evidence

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

Technological Characteristics

Mechanical distraction system consisting of bone plates, threaded rod, and activation instrument. Materials and design similar to predicate devices. Single patient use.

Indications for Use

Indicated for patients with totally or partially edentulous mandible or maxilla or small craniofacial bone deficiencies requiring increased bone height and mass via distraction osteogenesis, including those with traumatic defects, periodontal disease, or birth abnormalities.

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 1.0mm and 1.5mm System (K002152)
• Leibinger Chin Distractor (K973484)
• Lorenz Distraction System (K992952)

Submission Summary (Full Text)

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K030790

## 510(k) Summary

Device Proprietary Name:

Device Common Name:

Classification Name:

Name of Submitter:

OsteoMed Alveolar Distraction System

Intraoral Distractor

MQN. External Mandibular Fixator and/or Distractor

OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: [phone] Fax: [phone]

Contact Person:

Date Prepared:

Dawn T. Holdeman

March 10, 2003

Summary:

This submission describes the OsteoMed Alveolar Distraction System intended for use in patients who have totally or partially edentulous mandible or maxilla or small craniofacial bone deficiencies and need an increase in bone height and mass by means of distraction osteogenesis. These patients include those who have traumatic defects, periodontal disease or birth abnormality. The alveolar distractor is designed to provide temporary stabilization and gradual expansion across an osteotomy in the mandibular bone or maxillary bone and thereby increasing the height of the adiacent alveolar ridge. This device is intended to be removed after consolidation of the callus and prior to final prosthetic reconstruction. The OsteoMed Alveolar Distraction System is intended for single patient use only.

The OsteoMed Alveolar Distraction System is a distraction osteogenesis system consisting of two bone plates, a threaded rod and an activation instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with the activation instrument. The distractor is capable of distraction lengths of up to 20mm.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin TRACK 1.0mm and 1.5mm System (K002152), the Leibinger Chin Distractor (K973484), and the Lorenz Distraction System (K992952).

Due to the similarity of materials and design to predicate devices, OsteoMed believes that the OsteoMed Intraoral Distraction System does not raise any new safety or effectiveness issues.

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Public Health Service

SEP 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Dawn T. Holdeman Regulatory Affairs and Document Control OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001

Re: K030790

Trade/Device Name: Osteomed Alveolar Distraction System Intraoral Distractor Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: June 16, 2003 Received: June 17, 2003

Dear Ms. 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 vour 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 -Mr. Holdeman

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 vour 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/dsma/dsmamain.html

Sincerely vours.

Suzafunz

Susan Runner, DDS, MA Interim 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:

03079

| Device Name: | Osteomed Alveolar Distraction System |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | Intended for use in patients who have totally or<br>partially edentulous mandible or maxilla or small<br>craniofacial bone deficiencies and need an<br>increase in bone height and mass by means of<br>distraction osteogenesis. These patients include<br>those who have traumatic defects, periodontal<br>disease or birth abnormality. The distractor is<br>designed to provide temporary stabilization and<br>gradual expansion across an osteotomy in the<br>mandibular bone or maxillary bone and thereby<br>increasing the height of the adjacent Alveolar ridge.<br>This device is intended to be removed after<br>consolidation of the callus and prior to final<br>prosthetic reconstruction.<br>The OsteoMed Alveolar Distraction System is<br>intended for single patient use only. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 810.109) Over-The Counter-Use (Optical Format 1-)

Kein Muly for MSR

(Divis Division of Anesthesiolo Infection Control, Denta

510(k) Number: K030746