The TRIWAY® TTC Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:

Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
Rheumatoid arthritis with severe deformity
Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
Revision of failed total ankle arthroplasty with subtalar intrusion
Talar deficiency conditions, including avascular necrosis (requiring a tibiocalcaneal arthrodesis)
Neuroarthropathy or neuromuscular deformity or other neuromuscular disease with severe deformity of the ankle, including Charcot foot
Severe pilon fractures with trauma to the subtalar joint
Malunited tibial pilon fractures
The addition of an IBS™ 6.5mm compression screw through the subtalar joint and through the nail is required.

Device Description

The TRIWAY® Tibiotalocalcaneal (TTC) Arthrodesis System is composed of an angulated nail available in several sizes and different screws for bony fixation. Rigid fixation is achieved by screws.
An instrument set is available for the bone preparation, screw sizing and insertion of the TRIWAY® TTC Arthrodesis System. A specific targeting device is available for the positioning and the insertion of the different cotter screws and the I.B.S® 6.5mm compression screw, which is inserted in an oblique way to provide additional compression throughout the nail, between the calcaneus and the talus.
Sizes:
The TRIWAY® Arthrodesis Nail is available in several sizes, with left and right versions (diameter 10, 11, 12mm, lengths from 160mm to 250mm).
Cotter screws are available in 5.0mm diameter, with length ranging from 25 to 110mm by 5mm increment.
Material: The TRIWAY® TTC Arthrodesis System implants (nail and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136.
Single use: The TRIWAY® TTC Arthrodesis System is designed for single use only.
Sterilization: The TRIWAY® TTC Arthrodesis System is supplied sterile, using gamma irradiation.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System) and discusses its substantial equivalence to predicate devices, focusing on mechanical performance and material properties. It does not describe an AI medical device or a study involving human readers or expert ground truth for image interpretation. Therefore, I cannot extract the information required by your requests, as those particulars relate to the evaluation of AI-powered diagnostic or assistive devices.

The document discusses:

Device description: An intramedullary fixation rod system for tibiotalocalcaneal arthrodesis.
Material: Ti6Al4V, as per ISO 5832-1 and ASTM F136.
Sterilization: Gamma irradiation, supplied sterile.
Performance testing: "Performance testing of the TRIWAY® TTC Arthrodesis System was assessed through mechanical bench testing performed by an independent test laboratory. Testing performed included static and dynamic bending tests on TRIWAY® TTC Arthrodesis System. The results indicate that the TRIWAY® TTC Arthrodesis System met the acceptance criteria."
Pyrogen testing: Limulus Amebocyte Lysate (LAL) test in accordance with ANSI/AAMI ST72:2011.

It does not contain information about:

Acceptance criteria for an AI device.
Device performance metrics like accuracy, sensitivity, or specificity for an AI.
Sample sizes for test or training sets for an AI.
Data provenance (country, retrospective/prospective) for an AI.
Number of experts or their qualifications for establishing ground truth for AI.
Adjudication methods.
MRMC comparative effectiveness studies.
Standalone algorithm performance.
Types of ground truth (e.g., pathology, outcomes data) for an AI training set.

Summary

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March 15, 2018

In2Bones SAS % Christine Scifert Executive Vice President MRC-X, LLC 6075 Poplar Avenue, suite 500 N Memphis, Tennessee 38119

Re: K173811

Trade/Device Name: TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: December 14, 2017 Received: December 15, 2017

Dear Christine Scifert:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173811

Device Name

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System

Indications for Use (Describe)

The TRIWAY® TTC Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:

· Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
· Rheumatoid arthritis with severe deformity
· Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
· Revision of failed total ankle arthroplasty with subtalar intrusion
· Talar deficiency conditions, including avascular necrosis (requiring a tibiocalcaneal arthrodesis)
· Neuroarthropathy or neuromuscular deformity or other neuromuscular disease with severe deformity of the ankle, including Charcot foot
· Severe pilon fractures with trauma to the subtalar joint
Malunited tibial pilon fractures

The addition of an IBS™ 6.5mm compression screw through the subtalar joint and through the nail is required.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

| X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is set on a gray oval shape. The text "IN2BONES" is in white, with the "2" in orange.

For TRIWAY® Tibiotalocalcaneal (TTC) Arthrodesis System

Sponsor identification	In2Bones SAS28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29
Establishment registration number	3010470577
Date of preparation	December 13th, 2017
Contact person	Christine Scifert, MS, MEMMRC-X, LLC6075 Poplar Avenue, Suite 500Memphis, TN 38119Cell: 901-831-8053Email: Christine.Scifert@mrc-x.com
Proprietary Name	TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
Common name	Tibiotalocalcaneal (TTC) Arthrodesis System
Device classification regulation	21 CFR 888.3020: Intramedullary fixation rodClass II
Device Product Code and Panel	HSB: nailHWC: screw, fixation, bone87 orthopedics
DeviceDescription	The TRIWAY® Tibiotalocalcaneal (TTC) Arthrodesis System iscomposed of an angulated nail available in several sizes anddifferent screws for bony fixation. Rigid fixation is achieved byscrews.
	An instrument set is available for the bone preparation, screw sizingand insertion of the TRIWAY® TTC Arthrodesis System. Aspecific targeting device is available for the positioning and theinsertion of the different cotter screws and the I.B.S® 6.5mmcompression screw, which is inserted in an oblique way to provideadditional compression throughout the nail, between the calcaneusand the talus.
	Sizes:The TRIWAY® Arthrodesis Nail is available in several sizes, withleft and right versions (diameter 10, 11, 12mm, lengths from 160mmto 250mm).Cotter screws are available in 5.0mm diameter, with length rangingfrom 25 to 110mm by 5mm increment.
	Material: The TRIWAY® TTC Arthrodesis System implants (nailand screws) are manufactured from Ti6Al4V, as per ISO 5832-1 andASTM F136.
	Single use: The TRIWAY® TTC Arthrodesis System is designedfor single use only.
	Sterilization: The TRIWAY® TTC Arthrodesis System is suppliedsterile, using gamma irradiation.
PredicateDevices	Primary Predicate:Panta Nail (K091788), Newdeal, Acquired by Integra LifeSciencesAdditional Predicate:
	T2 Ankle Arthrodesis Nail (K051590), Stryker
Indications foruse	The TRIWAY® TTC Arthrodesis System is intended for use intibiotalocalcaneal arthrodesis and treatment of trauma to thehindfoot and distal tibia. Examples include:• Post-traumatic and degenerative arthritis involving both ankle andsubtalar joints• Rheumatoid arthritis with severe deformity• Revision of failed ankle arthrodesis with subtalar involvement orwith insufficient talar body
	• Revision of failed total ankle arthroplasty with subtalar intrusion
Talar deficiency conditions, including avascular necrosis (requiring a tibiocalcaneal arthrodesis) Neuroarthropathy or neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle, including Charcot foot Severe pilon fractures with trauma to the subtalar joint Malunited tibial pilon fractures The addition of an IBS™ 6.5mm compression screw through the subtalar joint and through the nail is required.
Comparison of Indications and Technological characteristics and Substantial Equivalence Summary	The In2Bones TRIWAY® TTC Arthrodesis System is similar to the predicate devices Newdeal Panta Nail (K091788), and Stryker T2 Ankle Arthrodesis Nail (K051590) in indications for us, intended use, design, size ranges, principle of operation and materials.
Summary Performance Data	Performance testing of the TRIWAY® TTC Arthrodesis System was assessed through mechanical bench testing performed by an independent test laboratory.Testing performed included static and dynamic bending tests on TRIWAY® TTC Arthrodesis System. The results indicate that the TRIWAY® TTC Arthrodesis System met the acceptance criteria.
Pyrogen testing	The method used to make the determination that the device meets pyrogen limit specification is the Limulus Amebocyte Lysate (LAL) test in accordance with ANSI/AAMI ST72:2011: Bacterial endotoxins - Test methods, routine monitoring and alternative to batch testing.
Conclusion	Based on the comparison of indications for use and technological characteristics and the results of the testing performed, the TRIWAY® TTC Arthrodesis System is substantially equivalent to the predicate devices identified in the 510(k) submission.

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Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.