(90 days)
Not Found
No
The description focuses on the mechanical components and intended surgical use of a bone fixation system, with no mention of AI or ML capabilities.
Yes
The device is intended for the treatment of various hindfoot conditions, including arthritis, deformity, and trauma, which aligns with the definition of a therapeutic device.
No
This device is an arthrodesis system, which is a surgical implant used for fixation and fusion of bones, not for diagnosing medical conditions.
No
The device description explicitly states it is composed of an angulated nail and screws made of Ti6Al4V, which are physical implants. It also mentions an instrument set and a targeting device, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for fusing bones in the ankle and hindfoot (tibiotalocalcaneal arthrodesis). This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The device is described as an angulated nail and screws made of titanium, designed for rigid fixation of bones. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo to treat a medical condition.
N/A
Intended Use / Indications for Use
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.
Product codes
HSB, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hindfoot and distal tibia, ankle and subtalar joints, tibiocalcaneal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
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 SAS
28 chemin du Petit Bois
69130 Ecully – France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment registration number | 3010470577 |
| Date of preparation | December 13th, 2017 |
| Contact person | Christine Scifert, MS, MEM
MRC-X, LLC
6075 Poplar Avenue, Suite 500
Memphis, TN 38119
Cell: 901-831-8053
Email: 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 rod
Class II |
| Device Product Code and Panel | HSB: nail
HWC: screw, fixation, bone
87 orthopedics |
| 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. |
| Predicate
Devices | Primary Predicate:
Panta Nail (K091788), Newdeal, Acquired by Integra LifeSciences
Additional Predicate: |
| | T2 Ankle Arthrodesis Nail (K051590), Stryker |
| Indications for
use | 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 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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