(123 days)
Not Found
No
The device description focuses on physical components (plates, screws, instruments) and material standards, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is used in reconstructive surgery and selective orthognathic surgeries, implying it is intended to treat a condition by supporting or replacing biological structures. This aligns with the definition of a therapeutic device.
No
This device is described as a system of bone plates, bone screws, and associated instruments for use in oral and maxillofacial surgery (reconstructive surgery, selective trauma, and selective orthognathic surgeries). This indicates it is an interventional or therapeutic device used for structural support, not for diagnosing a condition.
No
The device description explicitly states it is composed of bone plates, bone screws, and associated accessories (screwdrivers, forceps, drills), which are all physical hardware components.
Based on the provided information, the ORTRAUTEK ORTHOGNATHIC SYSTEM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it is for surgical procedures (oral, maxillofacial surgery, trauma, reconstructive surgery, orthognathic surgeries) involving the maxilla and mandible. This is an in vivo application, meaning it is used within the living body.
- Device Description: The device is composed of bone plates, bone screws, and surgical instruments. These are all physical implants and tools used directly in surgery, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ORTRAUTEK ORTHOGNATHIC SYSTEM is a surgical device used for fixation and reconstruction within the body.
N/A
Intended Use / Indications for Use
The ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.
Product codes
JEY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla and mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K854886, K974555, K021618, K944561, K944565, K953385, K012910
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
2
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.
3
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): |