OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM by OSTEOMED L.P.

The OsteoMed External Mandibular Distraction System, which is a family of external distraction osteogenesis devices for bone elongation for the correction of congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible that require gradual distraction.

The OsteoMed External Mandibular Distraction System is intended for use in either adults or pediatric patients.

The OsteoMed External Mandibular Distraction System is intended for single patient use only.

Device Description

This submission describes the OsteoMed External Mandibular Distraction System, which is a family of external distraction osteogenesis devices for bone elongation for the correction of congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible that require gradual distraction. This system is intended for use in either adults or pediatric patients. The OsteoMed External Mandibular Distraction System is intended for single patient use only.

The OsteoMed External Mandibular Distraction System is comprised of interchangeable distraction rods that connect to a posterior and anterior pin clamp, and/or the middle link. The anterior pin clamp can accommodate variations in pin placement. The pin clamps will accept 1.6 mm to 3.2 mm pins and lock to the pins via screws. The interchangeable distraction rods are available in various lengths for distraction up to 70 mm. The distraction rods are activated by a hex driver.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) summary for the OsteoMed External Mandibular Distraction System. It describes the device, its intended use, and claims substantial equivalence to several legally marketed predicate devices. The FDA's letter confirms this substantial equivalence determination.

However, the provided text does not contain:

A table of acceptance criteria or reported device performance.
Details about sample sizes, data provenance, or expert qualifications for a test set.
Information on adjudication methods or MRMC studies.
A standalone algorithm performance study.
The type of ground truth used.
Sample size or ground truth establishment for a training set.

The basis for market clearance in this document is a determination of substantial equivalence to existing devices, meaning its materials, design, and operational principle are similar and it does not raise new safety or effectiveness issues, rather than performance against specific acceptance criteria in a dedicated study.

Summary

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K 063792

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510(k) Summary

MAR 02 2007

Device Proprietary Name:	OsteoMed External MandibularDistraction System
Device Common Name:	External Distraction System
Classification Name:	MQN, External MandibularFixation and/or Distractor
Sponsor:	OsteoMed L. P.3885 Arapaho RoadAddison, Texas 75001Phone: (972) 677-4600Fax: (972) 677-4601
Contact Person:	Piedad Peña
Date Prepared:	February 14, 2007

Summary:

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin 3DX External Distraction System (K034027), the KLS-Martin LP, MOD Line of Molina Distractors 51-600 Series (K994154), Synthes (USA) External Multi Vector Mandible Distractor (K981362), and Lorenz External Mandibular Distractor (K992873).

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

Image /page/0/Picture/11 description: The image shows a logo with the word "Colson" inside a black circle. A white line runs vertically through the word. To the right of the circle, the text "A COLSON ASSOC" is written in a smaller, sans-serif font. The logo appears to be for a company or organization named Colson Associates.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 2 2007

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

Re: K063792

Trade/Device Name: OsteoMed External Mandibular Distraction System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: December 14, 2006 Received: December 22, 2006

Dear 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 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.

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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 (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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sudite Y. Michie Dmd

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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K063792

Indications for Use

510(k) Number (if known): _

Device Name: OsteoMed External Mandibular Distraction System

Indications for Use:

The OsteoMed External Mandibular Distraction System is intended for use in either adults or pediatric patients.

The OsteoMed External Mandibular Distraction System 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)

Page __ of _

(Posted November 13, 2003)

Susan Cunnon

nelel Hospial.

R063792

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
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.(b)
Classification. Class II.