OSA RIGID INTERNAL FIXATION SYSTEM

K021618 · Osteomed Corp. · JEY · Aug 8, 2002 · Dental

Device Facts

• Record ID: K021618
• Device Name: OSA RIGID INTERNAL FIXATION SYSTEM
• Applicant: Osteomed Corp.
• Product Code: JEY · Dental
• Decision Date: Aug 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsteoMed OSA Rigid Internal Fixation System is intended for a variety of pan facial indications. Specifically, the system is intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and mandible. Implants are single use only.

Device Story

System consists of bone plates (0.8mm–1.0mm thick) and screws (1.6mm–2.0mm diameter; 4.0mm–8.0mm length) with associated safety screws (1.9mm–2.4mm). Includes manual surgical instruments: depth gauges, screwdrivers, countersinks, and pilot drills. Used by surgeons in clinical settings for internal fixation of bone segments during facial/craniofacial procedures. Provides mechanical stabilization of bone fractures or osteotomies to facilitate healing. Single-use implants.

Clinical Evidence

No clinical data. Substantial equivalence based on design and material similarities to predicate devices.

Technological Characteristics

System comprises titanium bone plates and screws. Manual instrumentation includes depth gauges, screwdrivers, countersinks, and pilot drills. Mechanical fixation device; non-powered. Single-use implants.

Indications for Use

Indicated for patients requiring rigid internal fixation for midface and craniofacial skeleton trauma, craniofacial surgery, reconstructive procedures, and orthognathic surgery of the maxilla and mandible.

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

• Synthes 1.5mm/2.0mm Orthognathic Plates and Screws system (K980199)
• KLS Martin Lindorf System (K944565)
• Leibinger Profil-O-Plastic, Titanium Implant System

Submission Summary (Full Text)

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AUG 0 8 2002

K021618

## 510(k) Summary

| Device Proprietary Name: | OsteoMed OSA Rigid Internal<br>Fixation System |
|--------------------------|------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Bone Plate |
| Classification Name: | Plate, Bone |
| Name of Submitter: | OsteoMed Corporation<br>3750 Realty Road<br>Addison, Texas 75001<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | May 15, 2002 |

Summary:

This submission describes the OsteoMed OSA Rigid Internal Fixation System intended for use in a variety of pan facial indications. Specifically, this system is intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and mandible.

The OsteoMed OSA Rigid Internal Fixation System is comprised of various plates and screws. Plates, .8mm through 1.0mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm and 2.0mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 1.9mm and 2.4mm diameter. Depth gauges, screwdrivers, countersinks, pilot drills, and preparation instruments will also be a part of the system.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Synthes 1.5mm/2.0mm Orthognathic Plates and Screws system (K980199), the KLS Martin Lindorf System (K944565), and the Leibinger Profil-O-Plastic, Titanium Implant System.

Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed OSA Rigid Internal Fixation System does not raise any new safety or effectiveness issues.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.

AUG 0 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Dawn T. Holdeman Regulatory Affairs and Document Control OsteoMed Corporation 3750 Realty Road Addison, Texas 75001-4311

K021618 Re:

> Trade/Device Name: OSA Rigid Internal Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: May 15, 2002 Received: May 16, 2002

.

Dear Ms. Holdeman:

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. Holdeman

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely,

Timothy A. Ulatowski

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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## OsteoMed "Intended Use" Submission

K021618

| Device Name: | OsteoMed OSA Rigid Internal Fixation System |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | OsteoMed OSA Rigid Internal Fixation System is<br>intended for a variety of pan facial indications.<br>Specifically, the system is intended for selective<br>trauma of the midface and craniofacial skeleton;<br>craniofacial surgery; reconstructive procedures; and<br>selective orthognathic surgery of the maxilla and<br>mandible. Implants are single use only. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1 (Per 21 CFR 810.109)

510(k) Number:

Over-The Counter-Use (Optical Format 1-)

Susan Ruarrer

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

510(k) Number.***_****_*