NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR

K021342 · Osteomedics, Inc. · JEY · Aug 1, 2002 · Dental

Device Facts

• Record ID: K021342
• Device Name: NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
• 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 Bi-Directional / Multi-Directional Jaw Distractor is identical to the description in the 510 (k) number K952847 in which, the Normed Bi-Directional / Multi-Directional Jaw Distractor is designed for use in bone elongation which takes into account and can reproduce the normal size and shape of the facial skeleton. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Bi-Directional / Multi-Directional Jaw Distractor. This Normed Bi -Directional / Multi-Directional Jaw Distractor device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are, sever open mandibular fractures, highly comminuted closed fractures, nonunion and delayed union, fractures associated with infection, tumor resections, facial deformity corrections, and bone - grafting defects.

Device Story

External mandibular fixator and distractor; facilitates gradual bone elongation via distraction osteogenesis. Device applied to maxillofacial/craniofacial bones to correct skeletal size/shape. Operated by surgeons in clinical settings. Provides mechanical distraction to lengthen callus. Benefits patients by correcting facial deformities and treating complex fractures or bone defects. Device is identical to predicate K952847.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical design and technological characteristics to the predicate device.

Technological Characteristics

External mandibular fixator/distractor for bone elongation. Mechanical device; no software or energy source. Materials, sterilization, and design specifications are identical to predicate K952847.

Indications for Use

Indicated for bone elongation and distraction osteogenesis in maxillofacial alveolar and small craniofacial skeletal bones. Used for severe open/comminuted mandibular fractures, nonunion/delayed union, infection-associated fractures, tumor resections, facial deformity corrections, and bone-grafting defects. Contraindicated in patients with insufficient bone, poor bone quality, or systemic conditions/habits (e.g., uncontrolled diabetes, blood dyscrasias, AIDS, malignancy, heavy smoking, poor oral hygiene) impairing 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 Bi-Directional / Multi-Directional Jaw Distractor (K952847)

Submission Summary (Full Text)

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# AUG 01 2002

### 510 (k) Summary

510 (k) Number: K952847

K021342

Device Name: Normed Bi-Directional / Multi-Directional Jaw Distractor

Device Identification: External Mandibular Fixator and/or Distractor

Regulatory Class: II

Product Code: Product Code: JEY

Introduction of Normed Bi-Directional / Multi-Directional Jaw Distractor 510 (k) number K952847, by an additional distributor, Osteomedics® Inc.

The Normed Bi-Directional / Multi-Directional Jaw Distractor is authorized by Food and Drug Administration under the 510 (k) number K952847 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 K952847. The manufacturer, product design, product material, manufacturing process, device description, product intend use, labeling 2 quality assurance procedures, sterilization, substantial equivalency information and operational principal is identical to the information available in the 510 (k) number K952847

### Official Contact Person:

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

¹ 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 shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

#### Public Health Service

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: K021342

Trade/Device Name: Normed Bi-Directional/Multi-Directional Distractor 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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Page 2 -- Mr. Enayati

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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

[signature]

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for use

### 510 (k) Number (if known): K952847

Device Name: Normed Bi-Directional / Multi-Directional Jaw Distractor

### Indications for use:

The intended use of the Normed Bi-Directional / Multi-Directional Jaw Distractor is identical to the description in the 510 (k) number K952847 in which, the Normed Bi-Directional / Multi-Directional Jaw Distractor is designed for use in bone elongation which takes into account and can reproduce the normal size and shape of the facial skeleton. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Bi-Directional / Multi-Directional Jaw Distractor. This Normed Bi -Directional / Multi-Directional Jaw Distractor device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are, sever open mandibular fractures, highly comminuted closed fractures, nonunion and delayed union, fractures associated with infection, tumor resections, facial deformity corrections, and bone - grafting defects.

### Contraindications:

The Normed Bi-Directional / Multi-Directional Jaw Distractor 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 defined surgical protocol is required.

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

OR

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 Reaser

or Sign-Off) · ! Dental, Infection Control, Hospital Devices Aher -

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