OSTEOMED 2.0 LOCKING PLATES AND SCREWS

K030448 · Osteomed LP · JEY · May 9, 2003 · Dental

Device Facts

• Record ID: K030448
• Device Name: OSTEOMED 2.0 LOCKING PLATES AND SCREWS
• Applicant: Osteomed LP
• Product Code: JEY · Dental
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). 2.0 Locking plates and screws are intended for single patient use only.

Device Story

OsteoMed 2.0 Locking Plate System consists of bone plates (1.0mm–2.25mm thick) and 2.0mm diameter screws; used for fixation in oral, maxillofacial, trauma, reconstructive, and orthognathic surgeries. System includes manual surgical instruments: screwdrivers, drills, plate cutters, bending pliers, taps, and drill guides. Operated by surgeons in clinical/OR settings. Plates and screws are single-patient use. Device provides mechanical stabilization of bone segments to facilitate healing and reconstruction.

Clinical Evidence

No clinical data; substantial equivalence based on design and material similarity to predicate devices.

Technological Characteristics

Bone plate system; materials not specified; 2.0mm diameter screws; plate thickness 1.0mm–2.25mm; manual instrumentation; non-powered; non-implantable software.

Indications for Use

Indicated for patients requiring oral, maxillofacial, trauma, reconstructive, or orthognathic surgery for dentofacial deformities.

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 2.0 Locking Plate System (K974555)
• Stryker Locking Screw Mandibular Reconstruction Plate (K000594)
• Stryker Leibinger Newgen/Universal Mandibular System (K014263)

Submission Summary (Full Text)

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MAY - 9 2003

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K0 30448

## 510(k) Summary

| Device Proprietary Name: | OsteoMed 2.0 Locking Plate<br>System |
|--------------------------|-------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Bone Plate System |
| Classification Name: | Plate, Bone |
| Name of Submitter: | OsteoMed L. P.<br>3885 Arapaho Road<br>Addison, Texas 75001<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | May 6, 2003 |

Summary:

This submission describes the OsteoMed 2.0 Locking Plate System indicated for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). 2.0mm Locking Plates and screws are intended for single patient use only.

The OsteoMed 2.0 Locking Plate System is comprised of plates, 1.0mm through 2.25mm thick, provided in various shapes and sizes, and screws provided in 2.0mm diameter in lengths ranging from 6.0mm. System instruments include screwdrivers, drills, plate cutters, bending pliers, taps and drill guides.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Synthes 2.0 Locking Plate System (K974555), the Stryker Locking Screw Mandibular Reconstruction Plate(K000594), and the Stryker Leibinger Newgen/Universal Mandibular System(K014263).

Due to the similarity of materials and design to predicate devices. OsteoMed believes that the OsteoMed 2.0 Locking Plate System does not raise any new safety or effectiveness issues.

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Public Health Service

MAY - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Dawn T. Holdeman Regulatory Affairs & Document Control OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001

Re: K030448

Trade/Device Name: OsteoMed 2.0 Locking Plate system Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 6, 2003 Received: February 11, 2003

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 vour 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), 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.

Susan Runner

Susan Runner, DDS, MA Interim 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 "Indications for Use" Submission

510(k) Number:

| Device Name: | OsteoMed 2.0 Locking Plate System |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | Indicated for oral, maxillofacial surgery; trauma;<br>reconstructive surgery; and orthognathic surgery<br>(surgical correction of dentofacial deformities). 2.0<br>Locking plates and screws are intended for single<br>patient use only. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 810.109)

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

Kein Muhy for MSR

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

510(k) Number: K030448