OSTEO-MESH TM-300

K984230 · Osteogenics Biomedical, Inc. · JEY · Feb 4, 1999 · Dental

Device Facts

• Record ID: K984230
• Device Name: OSTEO-MESH TM-300
• Applicant: Osteogenics Biomedical, Inc.
• Product Code: JEY · Dental
• Decision Date: Feb 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For stabilization and support of bone grafts in dento-alveolar bony defect sites.

Device Story

Osteo-Mesh TM-300 is a titanium mesh used for stabilization and support of bone grafts in dento-alveolar bony defect sites. Fabricated from Grade 1 titanium; supplied nonsterile in two sizes (25 mm x 30 mm and 12 mm x 25 mm). Used by clinicians during dental surgical procedures to maintain graft positioning. Biocompatibility established via historical use of titanium.

Clinical Evidence

No clinical data provided. Biocompatibility is based on the long history of use of titanium in implant devices.

Technological Characteristics

Material: Grade 1 titanium per ASTM-F-67 or ISO equivalent. Form factor: Mesh in two sizes (25 mm x 30 mm and 12 mm x 25 mm). Nonsterile supply. No electronic or software components.

Indications for Use

Indicated for stabilization and support of bone grafts in patients with dento-alveolar bony defects.

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

• TRAM (Titanium Ridge Augmentation Material) (K963394)

Submission Summary (Full Text)

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4 1999 FEB

# 510 (k) SUMMARY

#### ADMINISTRATIVE 1.

Osteogenics Biomedical, Inc Submitter: 3234 64th Street Lubbock, TX 79413 [phone]

Contact Person: Chad Bartee

Date of Preparation: November 24, 1998

#### DEVICE NAME 11.

Proprietary Name: Osteo-Mesh™ TM-300 Common Name: Titanium Ridge Augmentation Mesh Classification Name: Bone Plate

#### PREDICATE DEVICE ll.

TRAM" (Titanium Ridge Augmentation Material); K963394: OsteoMed OsteoMed Corporation.

### IV. DEVICE DESCRIPTION

The Osteo-Mesh ™ TM-300 titanium ridge augmentation mesh is fabricated from Grade 1 titanium as described by ASTM-F-67 or its ISO equivalent. The Osteo-Mesh™ TM-300is supplied nonsterile in two sizes: 25 mm x 30 mm and 12 mm x 25 mm.

The biocompatibility of titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been performed with this device.

### V. INTENDED USE

For stabilization and support of bone grafts in dento-alveolar bony defect sites.

### VI. COMPARISON TO PREDICATE DEVICES

The Osteo-Mesh™ TM-300 is similar in composition, and intended use to legally marketed predicate devices, such as the OsteoMed TRAM™ (Titanium Ridge Augmentation Material).

Accordingly, Osteogenics Biomedical Inc. concluded that the Osteo-Mesh™ TM-300 is safe and effective for its intended use and performs at least as well as legally marketed predicate devices.

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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 1999

Osteogenics Biomedical, Incorporated C/O Mr. Richard A. Hamer Requlatory Consultant Richard Hamer Associates, Incorporated P.O.Box 16598 Fort Worth, Texas 76162-0598

K984230 Re: Osteo-Mesh TM-300 Trade Name: Regulatory Class: II Product Code: JEY 1998 Dated: November 24, November 25, 1998 Received:

Dear Mr. Hamer:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Hamer

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 acborizon in postantial 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Ulatowski r 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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Page 1 of 1

510(k) Number (if known):

Device Name:

Osteo - Mesh ™ TM-300 Titanium Ridge Augmentation Mesh

## Indications for Use:

For stabilization and support of bone grafts in dento-alveolar bony defect sites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div> <img alt="" src=""/> </div> | OR | Over-the-Counter Use |
|------------------------------------------|-----------------------------------|----|----------------------|
|------------------------------------------|-----------------------------------|----|----------------------|

(Optional Format 1-2-96)

| | <div> Susan Ranger </div> <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | KC984030 |