THE GNATHOMETER

K033092 · Ortho Gnathics, LLC · JEY · Apr 21, 2004 · Dental

Device Facts

• Record ID: K033092
• Device Name: THE GNATHOMETER
• Applicant: Ortho Gnathics, LLC
• Product Code: JEY · Dental
• Decision Date: Apr 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2

Intended Use

The Gnathometer is a jaw tracking apparatus designed to provide maxillofacial surgeons with an accurate means to measure distances relative to a defined three-dimensional reference system of x-y-z coordinates on the patient's head. The Gnathometer is intended for use only by maxillofacial surgeons performing corrective surgical procedures on patients with dentofacial deformittes. The Gnathometer's use during surgery is intended to assist in confirming the location and relocation of the patient's teeth and jaws with prescribed, pre-surgically designed relocations that remedy the patients dentofacial deformities. The Gnathometer is intended only to make contact with a patient at four (4) predetermined points on the skull via tightening screws and a halo device, and not to be attached to the jaws.

Device Story

The Gnathometer is a jaw tracking apparatus used by maxillofacial surgeons during corrective surgery. It functions as a mechanical measurement tool, establishing a 3D reference system (x-y-z coordinates) on the patient's skull. The device attaches to the patient at four predetermined points on the skull using a halo device and tightening screws; it does not attach to the jaws. By providing a stable reference frame, it allows surgeons to measure distances and confirm the precise location and relocation of teeth and jaws against pre-surgically planned positions. This assists in the accurate execution of corrective procedures for dentofacial deformities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical jaw tracking apparatus; utilizes a halo device with four-point skull fixation via tightening screws to establish a 3D coordinate reference system. Non-powered, manual measurement device.

Indications for Use

Indicated for patients with dentofacial deformities undergoing corrective maxillofacial surgery. Intended for use by maxillofacial surgeons to measure distances and confirm jaw/tooth relocation relative to a 3D coordinate system.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2004

Ortho Gnathics LLC C/O Mr. Kenneth J. Polk Kenneth J. Polk P.C. 5001 Baum Boulevard Suite 799 Pittsburgh, Pennsylvania 15213-1856

Re: K033092

Trade/Device Name: The Gnathometer Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 20, 2004 Received: February 23, 2004

Dear Mr. Polk:

We have reviewed your Scction 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, thereforc, 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. Polk

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,

Kevin Mcley

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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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K0330092

## STATEMENT OF INDICATIONS FOR USE SECTION F.

Page __ of _

510(k) Number (if known): _ Ko 33092

The Gnathometer Device Name:

Indications for Use:

The Gnathometer is a jaw tracking apparatus designed to provide maxillofacial surgeons with an accurate means to measure distances relative to a defined three-dimensional reference system of x-y-z coordinates on the patient's head. The Gnathometer is intended for use only by maxillofacial surgeons performing corrective surgical procedures on patients with dentofacial deformittes. The Gnathometer's use during surgery is intended to assist in confirming the location and relocation of the patient's teeth and jaws with prescribed, pre-surgically designed relocations that remedy the patients dentofacial deformities. The Gnathometer is intended only to make contact with a patient at four (4) predetermined points on the skull via tightening screws and a halo device, and not to be attached to the jaws.

(STEATE DO NOT WRITE BELOW THIS LINE-COMUNICE ON ANOTHER PACE OF MEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| 510(k) Number: | K033092 |
|----------------|---------|
|----------------|---------|

| Prescription Use | Over-The-Counter Use |
|---------------------|----------------------|
| (Per 21 FR 801.109) | |

(Optional Format 3-10-98)

Section F, Statement of Indications for Use, Page 1 of 1