CHIN DISTRACTOR

K973484 · Howmedica, Inc. · JEY · Dec 2, 1997 · Dental

Device Facts

• Record ID: K973484
• Device Name: CHIN DISTRACTOR
• Applicant: Howmedica, Inc.
• Product Code: JEY · Dental
• Decision Date: Dec 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use in patients requiring alveolar ridge augmentation of the mandible or maxilla secondary. This includes conditions secondary to trauma, periodontal disease or birth abnormality. The device is intended to provide temporary stabilization and gradual expansion of the alveolar ridge.

Device Story

Distraction osteogenesis system for alveolar ridge augmentation; consists of two titanium bone plates, threaded activation rod, and distraction instrument. Plates attach to bone via screws; distraction instrument activates threaded rod to gradually expand osteotomized segment. Used in clinical setting for patients with mandibular or maxillary ridge deficiencies. Provides temporary stabilization and gradual bone expansion. Benefits patient by correcting ridge defects secondary to trauma, disease, or congenital conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Titanium construction; mechanical distraction osteogenesis system; includes bone plates, threaded activation rod, and manual distraction instrument; bone screw fixation.

Indications for Use

Indicated for patients requiring alveolar ridge augmentation of the mandible or maxilla due to trauma, periodontal disease, or birth abnormality.

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

• Cohen Distractor (K972154)
• Luhr® Micro Mesh (K901940)
• Titanium Osteosynthesis System (K953385)
• Soft Tissue Expander (Versafil STE) Cox-Uphuff Int. (K874276)

Submission Summary (Full Text)

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K973484

## 510(k) Summary

## Device: Chin Distractor

The Chin Distractor is intended for use in patients requiring alveolar ridge augmentation of the mandible or maxilla. This includes conditions secondary to trauma, periodontal disease or birth abnormality. The device is intended to provide temporary stabilization and gradual expansion of the alveolar ridge. This device is a distraction osteogenesis system consisting of two bone plates, a threaded activation rod and a distraction instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with a distraction instrument. The implanted components of the device are manufactured from titanium.

The Chin Distractor is substantially equivalent to several other legally marketed devices. Examples of these are:

| 1. Cohen Distractor | Howmedica Leibinger | K972154 |
|--------------------------------------------------------|---------------------|---------|
| 2. Luhr® Micro Mesh | Howmedica | K901940 |
| 3. Titanium Osteosynthesis System | W. Lorenz Surgical | K953385 |
| 4. Soft Tissue Expander (Versafil STE) Cox-Uphuff Int. | | K874276 |

For information contact:

John Dichiara Group Regulatory Affairs Manager Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 [phone] Fax: [phone]

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1997

Mr. John Dichiara Group Regulatory Affairs Manager Howmedica Incorporated 359 Veterans Boulevard Rutherford, New Jersey 07070

K973484 Re : Chin Distractor Trade Name: Requlatory Class: II Product Code: JEY Dated: September 12, 1997 Received: September 15, 1997

Dear Mr. Dichiara:

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 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 (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. ರ್ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) 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

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Page 2 - Mr. Dichiara

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 regulation (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 A. Ulatowski

Timd Ulatowski ay A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): Unknown

Device Name: Chin Distractor

Indications for Use:

This device is intended for use in patients requiring alveolar ridge augmentation of the mandible or maxilla secondary. This includes conditions secondary to trauma, periodontal disease or birth abnormality. The device is intended to provide temporary stabilization and gradual expansion of the alveolar ridge.

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| Soncurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------|-------------------------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |

(Optional Format 1-2-96)