LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00

K990212 · Doctor'S Research Group, Inc. · DYX · Sep 14, 1999 · Dental

Device Facts

• Record ID: K990212
• Device Name: LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
• Applicant: Doctor'S Research Group, Inc.
• Product Code: DYX · Dental
• Decision Date: Sep 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is intended for secondary intermaxillary fixation in the treatment of maxillary and mandibular fractures, in elective orthognathic surgery and in the stabilization of dental and dentoalveolar injuries.

Device Story

The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is a mechanical device used by clinicians for secondary intermaxillary fixation. It provides stabilization for maxillary and mandibular fractures, elective orthognathic surgery, and dental/dentoalveolar injuries. The system is applied in a clinical setting to immobilize the jaw, facilitating healing or surgical correction. It functions as a mechanical fixation aid to maintain occlusion and jaw alignment post-injury or post-surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical intermaxillary fixation system. Materials and specific technical dimensions not disclosed in the provided documentation.

Indications for Use

Indicated for secondary intermaxillary fixation in patients requiring treatment for maxillary and mandibular fractures, elective orthognathic surgery, or stabilization of dental and dentoalveolar injuries.

Regulatory Classification

Identification

An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.

Submission Summary (Full Text)

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SEP 1 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. R. Ryan Elmore Engineering, DRG Doctor's Research Group, Incorporated 143 Wolcott Road Wolcott, Connecticut 06716

Re : K990212 Trade Name: DRG LockJaw™ 15 Minute Intermaxillary Fixation System Regulatory Class: II Product Code: DYX Dated: July 13, 1999 Received: July 14, 1999

Dear Mr. Elmore:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 — Mr. Elmore

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy M. Ulatowski

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Doctor's Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 [phone]

## Statement of indications for use

510(k) Number (if Known): _ K 990212

Device Name: DRG LockJaw™ 15 Minute Intermaxillary Fixation System

Indications for use:

The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is intended for secondary intermaxillary fixation in the treatment of maxillary and mandibular fractures, in elective orthognathic surgery and in the stabilization of dental and dentoalveolar injuries.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRG, Office of Device Evaluation (ODE)

Luriel W. Shurter

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use