(123 days)
The ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.
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.
I am sorry, but based on the limited information provided in the given text, I cannot describe the acceptance criteria and the study that proves the device meets them. The text primarily focuses on the 510(k) summary for the "ORTRAUTEK ORTHOGNATHIC SYSTEM," detailing its description, predicate devices, and intended use as part of its substantial equivalence claim to previously marketed devices.
There is no mention of:
- Acceptance criteria: Specific performance metrics or thresholds the device needs to meet.
- A study proving acceptance criteria: Details about any clinical or performance studies, their design, results, or statistical analyses.
- Sample sizes: For test sets or training sets.
- Data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document is a premarket notification (510(k)) that argues for substantial equivalence primarily based on material, design, composition, function, and intended use being identical or similar to predicate devices. It does not contain the kind of detailed performance study information typically found when a device is evaluated against specific acceptance criteria.
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Page 1 of 2
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 #: 33.4.78.97.00 Fax #: 33.4.78.97.63
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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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
§ 872.4760 Bone plate.
(a)
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.(b)
Classification. Class II.