(279 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, washers) and surgical instruments. There is no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is an implantable plate and screw system used for arthrodesis and fracture fixation, which falls under surgical repair rather than therapeutic treatment in the conventional sense of drug or energy-based therapy.
No
The device description indicates it is a plate system used for arthrodesis, fractures, osteotomies, and fusions, which are all surgical interventions or treatments, not diagnostic procedures.
No
The device description clearly states it consists of physical components like plates, screws, and washers, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Tornier Ankle Arthrodesis Plate System is a surgical implant used to stabilize bones in the ankle and foot. It is physically implanted into the body.
- Intended Use: The intended use is for surgical procedures like arthrodesis, fracture fixation, fusion, and osteotomy. These are all surgical interventions, not laboratory tests on specimens.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Tornier Ankle Arthrodesis Plate System is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, and fusions of small bones including the foot and ankle.
Product codes
HRS, HWC
Device Description
The Tornier Ankle Arthrodesis Plate System consists of minimally contoured plates, screws and washers. Reusable instruments are provided to facilitate fixation in total ankle arthrodesis and fracture fixation, fusion, and osteotomy of the bones of the foot. The Ankle Arthrodesis Plate System is made of stainless steel material or titanium material.
The Tornier Ankle Arthrodesis Plate System plates are not differentiated for Right or Left sides. The system includes an Anterior Tibio-Talar Plate (two sizes, plus an optional augmentation plate), a Lateral Tibio-Talar Plate (three sizes), and a Lateral Tibio-Talar-Calcaneal Plate (three sizes). The screws are provided in one diameter and in various lengths. The washers are provided in one size.
The system consists of sheaths that are attached to the bone plate by screws to cover the bone screws in bone plates. The osteosynthesis screws are driven into the bone through holes in the plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle joint and distal tibia, foot and ankle
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K090139 '1/2
SECTION 7
OCT & 7 2009
510 (k) SUMMARY
The following information summarizes the safety and effectiveness information upon which the substantial equivalence determination for the Tornier Ankle Arthrodesis Plate System is based.
| Prepared: | Friday, December 05, 2008 |
|---|---|
| Applicant: | Tornier, Inc. |
| 3601 West 76th Street | |
| Suite 200 | |
| Edina, MN 55435 | |
| Registration Number: 9100540 | |
| Telephone: | 978-232-9997 |
| Fax: | 978-232-9998 |
| Contact: | Brahim Hadri (Sr. Regulatory Affairs Specialist (RAC US)) |
| Device Name: | Ankle Arthrodesis Plate System |
| Device Trade Name: | (tbd) |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3030, Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Product Code: | HRS |
| Predicate Devices: | The Tornier Ankle Arthrodesis Plate System includes 3 types |
| of plates. An Anterior Tibio-Talar Plate,A Lateral Tibio-Talar-Plate,And a Lateral Tibio-Talar-Calcaneal Plate: The Anterior Tibio-Talar Plate is substantially equivalent to | |
| the Synthes LCP Ankle Arthrodesis Plate, K061940. | |
| The Lateral Tibio-Talar Plate is substantially equivalent to the | |
| Synthes LCP Ankle Arthrodesis Plate, K061940, and the | |
| Newdeal TTC Plates, K060473. | |
| The Lateral Tibio-Talar-Calcaneal Plate is substantially | |
| equivalent to the Newdeal TTC Plates, K060473. |
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1
×09013
SECTION 7
510 (k) SUMMARY (continued)
Device Description
The Tornier Ankle Arthrodesis Plate System consists of minimally contoured plates, screws and washers. Reusable instruments are provided to facilitate fixation in total ankle arthrodesis and fracture fixation, fusion, and osteotomy of the bones of the foot. The Ankle Arthrodesis Plate System is made of stainless steel material or titanium material.
The Tornier Ankle Arthrodesis Plate System plates are not differentiated for Right or Left sides. The system includes an Anterior Tibio-Talar Plate (two sizes, plus an optional augmentation plate), a Lateral Tibio-Talar Plate (three sizes), and a Lateral Tibio-Talar-Calcaneal Plate (three sizes). The screws are provided in one diameter and in various lengths. The washers are provided in one size.
The system consists of sheaths that are attached to the bone plate by screws to cover the bone screws in bone plates. The osteosynthesis screws are driven into the bone through holes in the plates.
Indications for Use
The Tornier Ankle Arthrodesis Plate System is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, and fusions of small bones including the foot and ankle.
Conclusion:
The Tornier Ankle Arthrodesis Plate System is substantially equivalent to commercially marketed devices, the Synthes LCP Anterior Ankle Arthrodesis Plate, K061940 and the Newdeal Advansys 1 1 T.C.P. (Tibio Talo Calcaneus Plate) K060473; The Tornier Ankle Arthrodesis Plate System does not raise any new issues of scientific technology, safety or effectiveness.
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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 consists of a stylized eagle with its wings spread, facing right. The eagle is black and has a simple, graphic design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The text is in uppercase letters and is also black.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT 2 7 2009
Tornier, Inc % Mr. Brahim Hadri 100 Cummings Center, Suite 444C Beverly, MA 01915
Re: K090139
Trade/Device Name: Tornier Ankle Arthrodesis Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: September 16, 2009 Received: September 16, 2009
Dear Mr. Hadri:
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 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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Brahim Hadri
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdr//mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 6 Indications for Use Statement
Indications for Use 510(k) Number (if known): NA KOGO139
Device Name: Ankle Arthrodesis Plate System
Indications for Use:
The Tornier Ankle Arthrodesis Plate System is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, and fusions of small bones including the foot and ankle.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jauta for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090139
510k Submission: Tornier Ankle Arthrodesis Plate System
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