NORMED BONE TRANSPORT DISTRACTION DEVICE

K021341 · Osteomedics, Inc. · JEY · Aug 1, 2002 · Dental

Device Facts

• Record ID: K021341
• Device Name: NORMED BONE TRANSPORT DISTRACTION DEVICE
• Applicant: Osteomedics, Inc.
• Product Code: JEY · Dental
• Decision Date: Aug 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Normed Transport Distraction Device is described and is identical to the 510 (k) number K990140 in which, the Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Transport Distraction Device. This Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are as follows: - Tumor Resections - Severe trauma which make continuous bone segments no longer possible . - Bone grafting defects . - Sever open mandibular fractures . - Facial deformity corrections

Device Story

External mandibular fixator and distractor; used for distraction osteogenesis to increase bone height and mass. Device facilitates gradual lengthening of callus in maxillofacial alveolar and small craniofacial skeletal bones. Operated by surgeons in clinical settings. Device is a mechanical system; no software or electronic components. Provides structural support and controlled distraction force to bone segments. Benefits patients by correcting skeletal defects, trauma, or deformities through bone regeneration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical design and manufacturing to the predicate device (K990140).

Technological Characteristics

External mandibular fixator and distractor. Mechanical device for distraction osteogenesis. No software, electronics, or energy source. Materials and specifications are identical to predicate K990140.

Indications for Use

Indicated for patients requiring distraction osteogenesis in totally or partially edentulous mandibles or maxillae, maxillofacial alveolar, and small craniofacial skeletal bones for tumor resections, severe trauma, bone grafting defects, severe open mandibular fractures, and facial deformity corrections. Contraindicated in patients with insufficient bone, poor bone quality, or systemic conditions/habits (e.g., uncontrolled diabetes, blood dyscrasias, hyperthyroidism, AIDS, alcohol/tobacco use, psychiatric disorders, oral infections, malignancies, recent myocardial infarction) that impair healing.

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

• Normed Bone Transport Distraction Device (K990140)

Submission Summary (Full Text)

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IC021341
AUG 01 2002

## 510 (k) Summary

510 (k) Number: 1990140-

Device Name: Normed Bone Transport Distraction Device

Device Identification: External Mandibular Fixator and/or Distractor

Regulatory Class: II

Product Code: Product Code: JEY

Introduction of Normed Bone Transport Distraction Device. 510 (k) number K990140, bv an additional distributor, Osteomedics®, Inc.

The Normed Bone Transport Distraction Device is authorized by Food and Drug Administration under the 510 (k) number K990140 to be distributed in the United States of America by Ace Surgical Supply Company, Incorporated . Osteomedics® Inc. is intended to be an additional distributor of the same device through out United States of America. The device intended to be introduced by Osteomedics® Inc., is the same identical product described in the 510 (k) number K990140. The manufacturer, product design, product material, manufacturing process, device description, product intend use, labeling', quality assurance procedures, sterilization, substantial equivalency information and operational principal is identical to the information available in the 510 (k) number K990140

## Official Contact Person:

Albert Enayati President Osteomedics® Inc. 809 Carter Lane Paramus, NJ 07652 Tel: [phone] Fax: [phone] E-mail: [e-mail]

Ace Surgical Supply Company, Incorporated, 1034 Pearl Street, P.O. Box 1710 Brockton , Massachusetts 02408

² Labeling will include Osteomedics® Inc. information.

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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 an eagle with three lines representing its wings or feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 01 2002

Mr. Albert Enayati President Osteomedics, Incorporated 809 Carter Lane Paramus. New Jersey 07652

Re: K021341

Trade/Device Name: Normed Bone Transport Distraction Device Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: July 23, 2002 Received: July 25, 2002

Dear Mr. Enayati:

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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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 and additionally 21 CFR Part 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" (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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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K021341

Indications for use

. 510 (k) Number (if known): K990140

Device Name: Normed Bone Transport Distraction Device

Indications for use:

The intended use of the Normed Transport Distraction Device is described and is identical to the 510 (k) number K990140 in which, the Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Transport Distraction Device. This Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are as follows:

- Tumor Resections ●
- Severe trauma which make continuous bone segments no longer possible .
- Bone grafting defects .
- Sever open mandibular fractures .
- Facial deformity corrections ●

## Contraindications:

The Normed Transport Distraction Device is contraindicated in patients with insufficient available bone, poor bone quality and generalized diseases, allergies or habits (uncontrolled diabetes, blood dycrasias, hyperthyroidism, AIDS, alcohol addictions, psychiatric disorders, oral infections, malignancies, myocardial infection within the last 12 months, heavy smoking, use of chewing tobacco, poor oral-hygiene, etc.) that may contribute to poor healing or osteogenesis formation of bone. The patient's good medical health status and history is mandatory. In addition, a radiographic evaluation to examine the anatomical condition of the patient for proper use of the device to the defined surgical protocol is required,

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription use /

OVER - THE - COUNTER USE

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Susan Runne

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

OR

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