DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3

K014001 · Oral Osteodistraction, L.P. · MQN · Feb 4, 2003 · Dental

Device Facts

• Record ID: K014001
• Device Name: DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3
• Applicant: Oral Osteodistraction, L.P.
• Product Code: MQN · Dental
• Decision Date: Feb 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oral Osteodistraction Distraction Rod Appliances is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

Device Story

Oral Osteodistraction Distraction Rod Appliances are intraoral devices used for mandibular bone distraction. Components include KLS Martin bone plates/screws, Ormco stainless steel crowns/Herbst rods, and Leone expansion screws. Device is placed subcutaneously and fixed to patient bone via screws. Craniofacial surgeon performs distraction by activating a geared rod mechanism using a hex key. Distraction rate is 0.5mm/day for the first 2 days, followed by 1mm/day. Gradual bone distraction facilitates bone growth for mandibular deficiency or post-traumatic reconstruction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Stainless Steel 304 (body) and 301 (pins). Distraction mechanism: Geared rod activated by hex key. Placement: Subcutaneous, intraoral. Fixation: Bone screws. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring gradual mandibular bone distraction due to mandibular deficiency or post-traumatic mandibular effects.

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 Intraoral Distractor (K973275)
• Synthes Mandibular Distractor (K962272)

Submission Summary (Full Text)

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K014001

## 510(K) SUMMARY (as required by 807.92(c))

FEB 0 4 2003

| Submitter of 510(k): | Oral Osteodistraction, L.P.<br>600 Lake Cook Rd., Suite 150<br>Buffalo Grove, IL 60089 | | |
|----------------------|----------------------------------------------------------------------------------------|--------------|--|
| | Phone: | 847-215-7554 | |
| | Fax: | 847-215-7563 | |
| Contact Person: | Yan Razdolsky | | |
| Date of Summary: | October 10, 2001 | | |
| Trade Name: | Oral Osteodistraction Distraction Rod Appliances (Rod 1, Rod 2<br>and Rod 3) | | |
| Classification Name: | External Mandibular Fixator and/or Distractor | | |
| Predicate Device: | | | |

| KLS-Martin | Intraoral Distractor | K973275 |
|------------|-----------------------|---------|
| Synthes | Mandibular Distractor | K962272 |

## Intended Use:

The Oral Osteodistraction Distraction Rod Appliances is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

## Device Description:

Distraction Osteogenesis Rod Appliances are used for mandibular bone distraction.

The major components include:

- 1. KLS Martin bone plates and screws.
- Ormco Stainless steel crowns, Herbst Rods. 2.
- 3. Leone expansion screws.

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# Comparison Chart

| | Oral Osteogenesis | KLS-Martin | Synthes |
|---------------------------|--------------------------------------------------|------------------------------|-----------------------------|
| Material | Stainless Steel 304 | TI - 6AL4V<br>Titanium Alloy | Surgical<br>Stainless Steal |
| Facial<br>Skeleton/Pins | Stainless Steel 301 | TI - 6AL4V<br>Titanium Alloy | Surgical<br>Stainless Steal |
| Distraction Rate | .5mm/day first 2 days then<br>1mm/day after that | 1mm/day | 1mm/day |
| Fixed to Patient<br>Bone | Screws | Screws | Screws |
| Completed<br>Distraction | Geared Rod | Geared Rod | Geared Rod |
| Distraction<br>Activation | Hex Key | Same | Screwdriver<br>External |
| Facial Bone<br>Distractor | Intraoral | Intraoral | Internal |
| Intended Use | Mandible Distraction | Same | Same |
| Device Placement | Subcutaneous | Same | Same |
| User | Craniofacial Surgeon | Same | Same |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 4 2003

Oral Osteodistraction, L.P. C/O Mr. Arthur J. Ward AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

Re: K014001

Trade/Device Name: Oral Osteodistraction Rod Appliances Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: November 26, 2002 Received: December 9, 2002

Dear Mr. Ward:

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 - Mr. Ward

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 [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 yours.

Susan Runres

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

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510(k) Number (if known): 长 0 | 中 ○ ○ |

Oral Osteodistraction Distraction Rod Appliances Device Name:

#### Indications For Use:

The Oral Osteodistraction Distraction Rod Appliances is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-

96)

Susan Rower

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K014001