OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED

K062851 · Osteomed LP · MQN · Nov 17, 2006 · Dental

Device Facts

• Record ID: K062851
• Device Name: OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED
• Applicant: Osteomed LP
• Product Code: MQN · Dental
• Decision Date: Nov 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Intended as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis), require gradual distraction. This system is intended for use in pediatric population for children under 4 years of age including infants and neonates. The OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended is intended for single patient use only.

Device Story

Subcutaneous bone distractor; used for mandibular lengthening/transport. System comprises curved/straight bars and plates fixed to bone via 1.2mm screws. Activated via threaded wire using hex driver; allows distraction up to 45mm. Used in clinical setting by surgeons. Provides gradual bone distraction to correct congenital or post-traumatic mandibular defects. Benefits patient by enabling bone growth/correction in pediatric population.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Subcutaneous bone distractor; features curved/straight bars and plates; 1.2mm bone screw fixation; threaded wire activation mechanism; manual operation via hex driver; distraction capacity up to 45mm; single-patient use.

Indications for Use

Indicated for pediatric patients under 4 years of age, including infants and neonates, requiring mandibular bone stabilization and lengthening/transport for congenital deficiencies or post-traumatic defects of the ramus, body, or symphysis.

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 Pediatric Intraoral Mandibular Distraction System (K043434)
• KLS-Martin LP, MOD Line of Molina Distractors 51-600 Series (K994154)

Submission Summary (Full Text)

{0}------------------------------------------------

K062851

Image /page/0/Picture/1 description: The image shows the logo for OsteoMed. The logo is in black and white and features the word "OsteoMed" in a bold, sans-serif font. The word is enclosed in an oval shape. The oval shape is also in black and white and has a thick border.

## 510(k) Summary

NOV 17 2006

| Device Proprietary Name: | OsteoMed Pediatric Intraoral<br>Mandibular Distraction System,<br>Extended |
|--------------------------|-------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Intraoral Distractor |
| Classification Name: | MQN, External Mandibular<br>Fixator and/or Distractor |
| Name of Submitter: | OsteoMed L. P.<br>3885 Arapaho Road<br>Addison, Texas 75001<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Piedad Peña |
| Date Prepared: | September 21, 2006 |

Summary:

This submission describes the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended indicated for use as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis) require gradual distraction. This system is intended for use in pediatric population for children under 4 years of age including infants and neonates. The OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended is intended for single patient use only.

The OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended is a subcutaneous bone distractor. It features various curved and straight bars, activated with a threaded wire, that have plates that are fixed to bone via 1.2mm 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 45mm.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the OsteoMed Pediatric Intraoral Mandibular Distraction System (K043434) and the KLS-Martin LP, MOD Line of Molina Distractors 51-600 Series (K994154).

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

OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001 [phone] FAX: [phone] Customer Service: [phone]

Image /page/0/Picture/11 description: The image shows the logo for "A Colson Associate". The logo consists of a black circle with a white vertical line through the center and the word "Colson" written in white letters inside the circle. To the right of the circle, the text "A Colson Associate" is written in black letters.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in providing health and human services to the nation.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2006

Ms. Piedad Peña Regulatory Affairs Associate OsteoMed. L.P. 3885 Arapaho Road Addison, Texas 75001

Re: K062851

Trade/Device Name: OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: September 22, 2006 Received: September 25, 2006

Dcar Ms. Pena:

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 adultcration.

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.

{2}------------------------------------------------

Page 2 - Ms. Pena

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 (OS) 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,

Snette Y. Michien Om.D,

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

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended

Indications for Use:

Intended as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis), require gradual distraction.

This system is intended for use in pediatric population for children under 4 years of age including infants and neonates.

The OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended is intended for single patient use only.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rump

gn-)
[sion of Anesthesiology, General Hospital,
f-bction Control, Dental Devices

Page __ of __

(Posted November 13, 2003) •••••••• Number