ORTRAUTEK ORTHOGNATHIC SYSTEM

K031989 · Tekka · JEY · Oct 28, 2003 · Dental

Device Facts

• Record ID: K031989
• Device Name: ORTRAUTEK ORTHOGNATHIC SYSTEM
• Applicant: Tekka
• Product Code: JEY · Dental
• Decision Date: Oct 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.

Device Story

The Ortrautek Orthognathic System consists of titanium bone plates and screws used for internal fixation in oral and maxillofacial surgery. The system includes various plate shapes/sizes (1.0mm, 0.6mm, 0.8mm thickness) and screws (2.0mm, 2.4mm, 1.5mm). Accessories include screwdrivers, forceps, and drills. Used by surgeons in clinical settings to stabilize bone segments during trauma repair, reconstruction, or orthognathic procedures. The device provides mechanical support to bone structures, facilitating healing and alignment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Bone plates (unalloyed titanium, ASTM F67) and bone screws (ASTM F136). Plate thicknesses: 0.6mm, 0.8mm, 1.0mm. Screw diameters: 1.5mm, 2.0mm, 2.4mm. Mechanical fixation system.

Indications for Use

Indicated for patients undergoing oral and maxillofacial surgery, including selective trauma, reconstructive surgery, and orthognathic procedures involving 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

• Wuerzburg Titanium Mini Bone Plate and Bone Screws (K854886)
• Synthes 2.0 MM Locking Plate System (2.0 LPS) (K974555)
• OSA Rigid Internal Fixation System (K021618)
• KLS-Martin Micro Osteosynthesis System (1.0mm) (K944561)
• KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565)
• Lorenz 1.00MM, 1.5MM, 2.0MM System (K953385)
• The Bioplate Mandible Fixation System (K012910)

Submission Summary (Full Text)

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Page 1 of 2

K031989

OCT 2 8 2003

## 501(k) SUMMARY

# SUMMARY OF SAFETY AND EFFECTIVENESS

APPLICANT :

TEKKA Parc Inopolis Route de Vourles 69230 Saint Genis Laval, France Tel #: [phone] Fax #: [phone]

Contact Person: Benoit Rodriquez Date Prepared: June 18, 2003

| DEVICE TRADE NAME: | ORTRAUTEK ORTHOGNATHIC SYSTEM |
|------------------------|-------------------------------|
| COMMON OR USUAL NAME: | Bone Plate System |
| CLASSIFICATION NAME: | Bone Plate |
| DEVICE CLASSIFICATION: | Class II, 21 CFR § 872.4760 |

### PREDICATE DEVICE:

K854886: Wuerzburg Titanium Mini Bone Plate and Bone Screws. K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS) K021618: OSA Rigid Internal Fixation System K944561: KLS-Martin Micro Osteosynthesis System (1.0mm) K944565: KLS-Martin Micro Osteosynthesis System (1.5mm) K953385: Lorenz 1.00MM, 1.5MM, 2.0MM System K012910: The Bioplate Mandible Fixation System

### DEVICE DESCRIPTION:

The ORTRAUTEK ORTHOGNATHIC SYSTEM is composed of bone plates and bone screws of various shapes and sizes, and associated accessories for use in oral and maxillofacial surgery. The accessories include the instruments used to implant bone plates and screws. These accessories include screwdrivers, forceps, and drills. The bone plates meet ASTM F67 standards of unalloyed titanium surgical implants. The bone screws meet ASTM F136 standards. The system contains various shapes and sizes of plates. The thickness of these plates is either 1.0 mm, 0.6 mm, or 0.8 mm. The system contains bone screws that are 2.0 mm, 2.4 mm, or 1.5MM.

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## BASIS OF SUBSTANTIAL EQUIVALENCE:

The ORTRAUTEK ORTHOGNATHIC System is identical in material, design, composition, function, and intended use to predicate devices. The intended use is similar to K97455 and K012901. The plates and screws are made of the same material as predicate devices. The system contains various shapes of plates and screws similar to predicate devices.

#### INTENDED USE:

The ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

OCT 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tekka C/O Mr. Fayyaz Memon Alta Medical Incorporated 6512 Bannockburn Drive Bethesda, Maryland 20817

Re: K031989

Trade/Device Name: Ortrautek Orthognathic System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: October 15, 2003 Received: October 15, 2003

Dear Mr. Memon:

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 - Mr. Memon

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,

Quls

Chiu Lin, Ph.D. 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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510(k) - Notification ORTRAUTEK ORTHOGNATHIC SYSTEM Exhibit 2, Page 1 of 1

# Indication for Use Statement

Applicant: TEKKA, France

510(K) Number: (if known): |< 0 3 \ 9 ≤ 9

ORTRAUTEK ORTHOGNATHIC SYSTEM Device Name:

#### Indication for Use:

The ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.

Kein Muling Sa MSR

Anesthesiolo ontrol. Dental

510(k) Number: K031989

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

Prescription Use: OR Over the Counter