ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)

K042278 · Oral Osteodistraction, L.P. · MQN · Jan 28, 2005 · Dental

Device Facts

• Record ID: K042278
• Device Name: ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
• Applicant: Oral Osteodistraction, L.P.
• Product Code: MQN · Dental
• Decision Date: Jan 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.

Device Story

The ROD 5 is a distraction osteogenesis appliance used by craniofacial surgeons to increase bone mass and height. The device consists of two bondable attachments and a horizontal rod spanning the distraction site. It is primarily tooth-borne, with a fixation wire attached to the bone; no bone screws are required. Activation is performed manually by a surgeon using a screwdriver to rotate the rod, which features spring washers and detents for a self-locking mechanism. The device provides a distraction rate of 1.0 mm/day. Removal is minimally invasive, requiring only the cutting of the fixation wire, which is then pulled through the bone and soft tissue without an incision. The device benefits patients by facilitating bone regeneration in areas otherwise inadequate for dental implants or restorative procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Polyurethane and stainless steel. Distraction mechanism: Horizontal rod with holes for .025" fixation wire. Activation: Manual screwdriver-actuated detent/spring washer system. Form factor: Tooth-borne appliance. Energy source: Manual mechanical activation.

Indications for Use

Indicated for patients requiring increased bone mass and height via distraction osteogenesis due to periodontal disease, trauma, post-tumor resection, ankylosed teeth, or atrophic bone areas insufficient for dental implants or restorative procedures.

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 Track Distractor (K002152)

Submission Summary (Full Text)

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K042278

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

JAN 2 8 2005

| Submitter of 510(k): | Oral Osteodistraction, L.P.<br>600 W. Lake Cook Rd., Suite 150<br>Buffalo Grove, IL 60089 | |
|-------------------------|-------------------------------------------------------------------------------------------|--|
| | Phone: [phone]<br>Fax: [phone] | |
| Contact Person: | Yan Razdolsky | |
| Date of Summary: | July 1, 2004 | |
| Trade/Proprietary Name: | Oral Osteodistraction Distraction Rod Appliance<br>(ROD 5) | |
| Classification Name: | External Mandibular Fixator and/or Distractor | |
| Product Code: | MQN | |
| Predicate Device: | KLS-Martin Track Distractor K002152 | |
| Intended Use: | | |

The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.

#### Device Description:

The device consists of two bondable attachments and a horizontal rod that spans the distraction site. the rod is supported by these attachments which are bonded to the teeth and has holes for engagement of distraction wire. The spring washers and detents allow for activation of the device during distraction and provide a self-locking mechanism to prevent deactivation of the device. The device is activated by a screwdriver, which is inserted in to the screwdriver slot, pushed against the washer to disengage the detent, and then rotated. The device is predominately - tooth bone, with only a fixation wire attached to the bone; no screws are required. Removal of the device requires only cutting the fixation wire. The wire can then be pulled through the bone and soft tissue without the need for an incision.

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# Comparison Chart

| | Oral Osteodistraction<br>ROD - 5 | KLS Martin Track<br>Distractor - K002152 |
|------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Material | Polyurethane and Stainless<br>Steel | T1-6AL-4V Titanium Alloy |
| Distraction Rate | 1.0 mm/day | Same |
| Distraction Mechanism | Rod with holes for distraction<br>wire (.025") attached through<br>pt. bone | Threaded rod with attached<br>titanium plates fixed to one<br>with titanium screws |
| Distraction Activation | Screwdriver | Same |
| Site of Distraction | Tooth-borne, bone borne<br>(wire only) | Bone borne |
| Target Use | Cranio/Facial surgeons | Same |
| Latency Period | 3-7 Days | 5-7 Days |
| Distraction Period | 7-14 Days | Same |
| Retention Period | 3-6 Weeks | Same |
| Intended Use | Maxillo Mandibular<br>deficiencies | Same |
| Surgical Technique | Osteotomy | 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 is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Public Health Service

JAN 2 8 2005

ood and Drug Administratio 00 Corporate Boulevard Rockville MD 20850

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

Re: K042278

Trade/Device Name: Oral Osteodistraction Distraction Rod Appliance (ROD 5) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: December 22, 2004 Received: January 21, 2005

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/industry/support/index.html.

Sincerely yours,

Chiu, Lin, Ph.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

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## Indications for Use

510(k) Number (if known): _ |< < < < > > 2 2 7 8

Device Name: Oral Osteodistraction Distraction Rod Appliance (ROD 5)

Indications for Use:

The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Sun. Rur

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

510(k) Number. K042278

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