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.

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.

AI/ML Overview

This document is a 510(k) summary for the Tornier Ankle Arthrodesis Plate System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria through a specific study. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance is not present in this document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not Applicable/Not Provided. The document does not describe specific performance-based acceptance criteria for the Tornier Ankle Arthrodesis Plate System, nor does it provide reported device performance metrics against such criteria. The entire 510(k) submission is about demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This means the device is considered safe and effective if it has the same intended use as a predicate device and its technological characteristics do not raise different questions of safety and effectiveness, or if it has different technological characteristics, but the information submitted demonstrates that the device is as safe and effective as a legally marketed predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Not Provided. This document does not describe any clinical or performance studies with a test set of human subjects or data. The evidence for substantial equivalence primarily relies on a comparison of device characteristics (design, materials, intended use, mechanical testing) to predicate devices. There's no mention of sample sizes, data provenance, or study design (retrospective/prospective) because this isn't a clinical trial report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Provided. As no clinical or data-driven test set is described, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not Provided. No test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable/Not Provided. This is not an AI-enabled device. Therefore, no MRMC comparative effectiveness study or AI-related performance is discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Not Provided. This is not an AI-enabled device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable/Not Provided. No ground truth data is discussed in the context of device performance testing in this summary. The "ground truth" for a 510(k) is usually the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not Applicable/Not Provided. This is not an AI-enabled device or a device developed through data-driven training.

9. How the ground truth for the training set was established

Not Applicable/Not Provided. This is not an AI-enabled device or a device developed through data-driven training.

Summary of the Study/Evidence Provided in the Document:

The "study" presented in this 510(k) summary is a substantial equivalence comparison to legally marketed predicate devices.

Device: Tornier Ankle Arthrodesis Plate System
Predicate Devices:
- Synthes LCP Ankle Arthrodesis Plate (K061940)
- Newdeal TTC Plates (K060473)
Methodology for Demonstrating Substantial Equivalence:
1. Identical Intended Use: The Tornier system's intended use ("arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, and fusions of small bones including the foot and ankle") is stated to be substantially equivalent to the predicates.
2. Similar Technological Characteristics: The document describes the Tornier system's components (minimally contoured plates, screws, washers made of stainless steel or titanium), design (not differentiated for right/left sides, specific plate types), and function (fixation). It then asserts that these characteristics do not raise new issues of safety or effectiveness compared to the predicates.
3. Performance Data: While not detailed in this summary, a full 510(k) submission would typically include bench testing (e.g., mechanical strength, fatigue testing) to ensure the new device performs comparably to the predicate or meets recognized standards relevant to its intended use. This summary implies that such data supports substantial equivalence, stating, "The Tornier Ankle Arthrodesis Plate System does not raise any new issues of scientific technology, safety or effectiveness."

Conclusion:

This 510(k) summary (K090139) is a regulatory document focused on demonstrating substantial equivalence to predicate devices, not on providing performance metrics against specific acceptance criteria from a clinical or AI-based study. The FDA's letter confirms their agreement that the device is substantially equivalent for the stated indications for use.

Summary

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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 StreetSuite 200Edina, MN 55435Registration 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 fixationappliances and accessories
Product Code:	HRS
Predicate Devices:	The Tornier Ankle Arthrodesis Plate System includes 3 typesof 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 tothe Synthes LCP Ankle Arthrodesis Plate, K061940.The Lateral Tibio-Talar Plate is substantially equivalent to theSynthes LCP Ankle Arthrodesis Plate, K061940, and theNewdeal TTC Plates, K060473.The Lateral Tibio-Talar-Calcaneal Plate is substantiallyequivalent to the Newdeal TTC Plates, K060473.

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×09013

SECTION 7

510 (k) SUMMARY (continued)

Device Description

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

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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

Page 8 of 63

Regulation Number and Section

§ 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.