ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4

K034045 · Oral Osteodistraction, L.P. · MQN · Mar 23, 2004 · Dental

Device Facts

• Record ID: K034045
• Device Name: ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4
• Applicant: Oral Osteodistraction, L.P.
• Product Code: MQN · Dental
• Decision Date: Mar 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.

Device Story

Device is an intraoral maxillary and midface distractor; used for reconstruction of craniofacial anomalies or underdeveloped maxilla. System comprises stainless steel crowns cemented to maxillary molars/bicuspids; features male/female precision attachments and Leone hyraax screws. Surgeon secures device to bone using bone plates and surgical mini screws. Operation involves manual activation via screwdriver inserted into hyraax screw slot; rotation drives distraction. Device is tooth-borne and internal. Output is controlled mechanical distraction of bone segments. Used by craniofacial surgeons in clinical settings. Benefits include correction of maxillary skeletal deficiencies through controlled osteodistraction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Stainless Steel 304 (device body), Stainless Steel 301 (pins). Mechanical distraction via geared rod and hyraax screws. Intraoral, tooth-borne placement. Manual activation via hex key/screwdriver. No software or electronic components.

Indications for Use

Indicated for patients with congenital and acquired craniofacial anomalies or narrow/underdeveloped maxilla requiring maxillary and midface osteodistraction.

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 Rigid External Distractor (K972047)
• Oral Osteodistraction Rod Appliances (Rod 1,2,3) (K014001)

Submission Summary (Full Text)

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MAR 2 3 2004

### 510(K) SUMMARY (as required by 807.92(c)) K034045

| Submitter of 510(k): | Oral Osteodistraction, L.P.<br>600 W. 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: | March 14, 2004 | | |
| Trade Name: | Oral Osteodistraction Distraction Rod Appliances (Rod 4) | | |
| Classification Name: | External Maxillary Fixator and/or Distractor - MQN | | |
| Predicate Device: | KLS Martin Rigid External Distractor K972047<br>Oral Osteodistraction Rod Appliances (Rod 1,2,3) K01400 | | |

### Intended Use:

The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.

### Device Description:

The device consists of two to four preformed stainless steel crowns, which are cemented over maxillary first permanent molars and first permanent bicuspids. Stainless steel crowns have male and female precision attachments welded to them prior to cementation. Three Leone hyraax screws are also welded to the above-described attachments (two on the buccal and one on the palatal surfaces). The device is activated by a screwdriver, which is inserted in to the screwdriver slot of the hyraax screw and then rotated. The device is predominately - tooth bone, with KILS bone plates attached to the bone. Surgical mini screws are required to secure bone plates to the bone. Removal of the device requires removal of mini screws and removal of the crows.

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# Comparison Chart

| | Oral Osteodistraction<br>ROD 1, 2, 3 -<br>K014001 | Oral Osteodistraction<br>Rod 4 | KLS Martin -<br>K972047 |
|---------------------------|---------------------------------------------------|--------------------------------|-----------------------------|
| Material | Stainless Steel 304 | Stainless Steel 304 | T1-6AL-4V Titanium<br>Alloy |
| Facial<br>Skeleton/Pins | Stainless Steel 301 | Stainless Steel 301 | T1-6AL-4V Titanium<br>Alloy |
| Distraction Rate | .5mm/day first 2 days<br>then 1mm/day after that | Same | 1 mm/day |
| Fixed to Patient<br>Bone | Screws | Screws | Screws |
| Completed<br>Distraction | Geared Rod | Geared Rod | Geared Rod |
| Distraction<br>Activation | Hex Key | Same | Same |
| Facial Bone<br>Distractor | Intraoral | Intraoral | Intraoral and External |
| Intended Use | Mandible Distraction | Maxillary | Maxillary |
| Device<br>Placement | Subcutaneous | Same | Same |
| User | Craniofacial Surgeon | Same | Same |

Rod 4 is essentially the same as Rods 1-3 except for the location of axis change.

## Additional Comparison

| | Oral Osteodistraction<br>ROD 1, 2, 3 – K014001 | Oral<br>Osteodistraction<br>Rod 4 | KLS Martin -<br>K972047 |
|----------------------|------------------------------------------------|-----------------------------------|-----------------------------|
| Site of Distraction | Tooth-borne | Tooth-borne | Tooth-borne and<br>External |
| Latency Period | 5-7 Days | Same | Same |
| Distraction Period | 7-14 Days | Same | Same |
| Consolidation Period | 8-12 Weeks | Same | Same |
| Surgical Technique | Osteotomy | Same | Same |
| Placement | Internal | Internal | External |

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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 a stylized symbol resembling an abstract eagle or bird with three curved lines representing its wings or feathers.

Public Health Service

MAR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K034045

Trade/Device Name: Oral Osteodistraction Distraction Rod Appliance (Rod 4) Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: December 1, 2003 Received: December 29, 2003

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 - Ms. Rivkowich

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 (OS) 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,

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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034045 510(k) Number (if known):

Oral Osteodistraction Distraction Rod Appliance (Rod 4) Device Name:

#### Indications For Use:

The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

Over-The-Counter Use (Optional Format 1-2-96)

Swen

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

510(k) Number: J