(89 days)
The ORTRAUTEK TRAUMA SYSTEM is a cranio-maxillofacial titanium plate and screw system intended for osteotomy, stabilization and rigid fixation of cranio-maxillofacial fracture and reconstruction.
The ORTRAUTEK TRAUMA 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 unalloved 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 or 0.6 mm. The system contains bone screws that are 2.0 mm, 2.4 mm, or 1.5 mm.
The provided document is a 510(k) summary for the ORTRAUTEK TRAUMA SYSTEM. This type of regulatory submission establishes substantial equivalence to predicate devices and does not typically include detailed performance studies with acceptance criteria, sample sizes, or ground truth establishment in the way that an AI/ML medical device submission would.
Therefore, the document does not contain the information required to populate the acceptance criteria and study details for an AI-based device.
The document discusses:
- Device Trade Name: ORTRAUTEK TRAUMA SYSTEM
- Common/Usual Name: Bone Plate System
- Classification Name: Bone Plate
- Predicate Devices: Several bone plate systems (K854886, K022185, K002619, K974555, K944561, K953385).
- Device Description: Composed of bone plates and bone screws made of unalloyed titanium (meeting ASTM F67 and F136 standards, respectively), and associated accessories.
- Intended Use: Cranio-maxillofacial titanium plate and screw system intended for osteotomy, stabilization, and rigid fixation of cranio-maxillofacial fracture and reconstruction.
- Basis of Substantial Equivalence: Identical in material, design, composition, function, and intended use to predicate devices.
There is no mention of acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes, ground truth, expert adjudication, or AI/ML-related studies within this document. This is a hardware device (bone plates and screws), not a software or AI-driven diagnostic/therapeutic device that would rely on such performance metrics.
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TEKKA 510(k) - Notification ORTRAUTEK TRAUMA SYSTEM
032520
NOV 1 2 2003
510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS
APPLICANT:
TEKKA Parc Inopolis Route de Vourles 69230 Saint Genis Laval France Tel #: 33.4.78.56.97.00 Fax #: 33.4.78.56.01.63
Contact Person: Benoit Rodriguez Date Prepared: August 8, 2003
| DEVICE TRADE NAME: | ORTRAUTEK TRAUMA 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. K022185: Stryker Instruments - Universal CMF System. K002619: Stryker Instruments - NewGen System K974555: Synthes 2.0 mm Locking Plate System (2.0 LPS) K944561: KLS-Martin Micro Osteosynthesis System (1.0 mm) K953385: Lorenz 1.00 mm, 1.5 mm, 2.0 mm System
DEVICE DESCRIPTION:
The ORTRAUTEK TRAUMA 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 unalloved 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 or 0.6 mm. The system contains bone screws that are 2.0 mm, 2.4 mm, or 1.5 mm.
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BASIS OF SUBSTANTIAL EQUIVALENCE:
The ORTRAUTEK TRAUMA SYSTEM is identical in material, design, composition, function, and intended use to predicate devices. The intended use is similar to K022185 and K002619. 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 TRAUMA SYSTEM is a cranio-maxillofacial titanium plate and screw system intended for osteotomy, stabilization and rigid fixation of cranio-maxillofacial fracture and reconstruction.
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Image /page/2/Picture/1 description: The image is a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. Inside the circle is a stylized graphic of three human profiles facing right, layered on top of each other, with flowing lines suggesting hair or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2003
Tekka C/O Mr. Fayyaz Memon Alta Medical Incorporated 6512 Bannockburn Drive Bethesda, Maryland 20817
Re: K032520
Trade/Device Name: Ortrautek Trauma System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 7, 2003 Received: August 16, 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,
Chiu Lin, Ph.D.
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 TRAUMA SYSTEM Exhibit 2, Page 1 of 1
Indication for Use Statement
TEKKA, France Applicant: 032526 510(K) Number: (if known):_
ORTRAUTEK TRAUMA SYSTEM Device Name:
Indication for Use:
The ORTRAUTEK TRAUMA SYSTEM is a cranio-maxillofacial titanium plate and screw system intended for osteotomy, stabilization and rigid fixation of cranio-maxillofacial fracture and reconstruction.
Suor Ruor
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: KC32500
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:_____________________________________________________________________________________________________________________________________________________________ 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.