(210 days)
No
The device description and performance studies focus on mechanical properties and surgical technique, with no mention of AI/ML components or data processing.
No
The device provides fixation during the healing process but does not directly treat a disease or condition itself. It's a support structure, not an active treatment.
No
This device is a surgical fixation system designed to provide stability during the healing process of syndesmotic trauma, not to diagnose medical conditions.
No
The device description explicitly states it is composed of physical components: two titanium alloy buttons and one UHMWPE suture, along with stainless steel, UHMWPE, and nylon instruments. This indicates it is a hardware-based medical device.
Based on the provided information, the TACTIX Vector Syndesmosis System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical fixation of bone fragments and syndesmosis disruptions. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a system of buttons and sutures designed to provide mechanical fixation during the healing process. This aligns with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or treatment decisions.
- Anatomical Site: The device is applied directly to the ankle bones, not used to process or analyze samples taken from the body.
In summary, the TACTIX Vector Syndesmosis System is a surgical implant intended for mechanical fixation, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the TACTIC Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Product codes
HTN
Device Description
The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma using a TACTIX Vector suture loop and buttons.
The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle (specifically for syndesmosis disruptions in connection with Weber B and C ankle fractures).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following nonclinical tests were performed for the TACTIX Vector Syndesmosis System:
- Cyclic fatigue testing compared against the additional predicate device (K173278)
- Static pullout testing compared against the additional predicate device (K173278)
- Stability testing on product packaging
- Packaging performance testing
- Biocompatibility evaluation per ISO 10993-1
- Bacterial endotoxin testing
The noncinical testing showed that the TACTIX Vector Syndesmosis System performs substantially equivalent to a predicate device. Therefore, the TACTIX Vector Syndesmosis System raises no new questions of safety or effectiveness and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2024
Vilex LLC Brock Johnson President 111 Moffitt Street McMinnville, Tennessee 37110
Re: K240035
Trade/Device Name: TACTIX Vector Syndesmosis System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: June 28, 2024 Received: July 11, 2024
Dear Mr. Johnson:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4. Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/cdrh-learn). 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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher Ferreira -S
for
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
TACTIX Vector Syndesmosis System
Indications for Use (Describe)
The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the TACTIC Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
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)
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3
| 510(k) #: | K240035 | | 510(k) Summary | | K240035
Prepared on: 2024-07-29 |
| ----------- | --------- | -- | ---------------- | -- | ------------------------------------ |
|---|
21 CFR 807.92(a)(1)
| Contact Details | |
|---|---|
| Applicant Name | Vilex LLC |
| Applicant Address | 111 Moffitt Street McMinnville TN 37110 United States |
| Applicant Contact Telephone | 8019164157 |
| Applicant Contact | Mr. Brock Johnson |
| Applicant Contact Email | brock.johnson@vilex.com |
21 CFR 807.92(a)(2)
| Device Name | |
|---|---|
| Device Trade Name | TACTIX Vector Syndesmosis System |
| Common Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification Name | Washer, Bolt Nut |
| Regulation Number | 888.3030 |
| Product Code | HTN |
21 CFR 807.92(a)(3)
| Legally Marketed Predicate Devices | ||
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant Syste | HTN |
| K173278 | ToggleLoc System (Only ToggleLoc with ZipTight Fixation Device | MBI |
| K230204 | Alphalok Plating System (reference device) | HRS |
21 CFR 807.92(a)(4)
| Device Description Summary |
|---|
| ---------------------------- |
The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma using a TACTIX Vector suture loop and buttons.
The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the TACTIC Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
4
Indications for Use Comparison
The indications for use of the TACTIX Vector Syndesmosis System are identical to the primary predicate device.
Technological Comparison
The TACTIX Vector Syndesmosis System is composed of two titanium alloy buttons and one UHMWPE suture. The predicate devices are also composed of two titanium alloy buttons and one UHMWPE suture. The TACTIX Vector suture and buttons have the same basic design and intended use as the suture and buttons of the predicate devices.
The TACTIX Vector Syndesmosis System uses a tension on the implanted suture loop. The predicate devices also utilize an instrument for the same intended use. The TACTIX Vector System uses a threader rod to install the suture. The predicate devices also use an instrument for the same intended use. The instruments of TACTIX System are composed of stainless steel, UHMWPE, and nylon material. The instruments of the predicate devices are composed of stainless materials.
The TACTIX Vector Syndesmosis System is intended for single use and provided sterile to the end user via ethylene oxide sterilization. The predicate devices are intended for single use and provided sterile to the end user via ethylene oxide sterilization.
Therefore, the technological characteristics of the TACTIX Vector System are substantially equivalent to those of the predicate device. The differences in the technological characteristics between the TACTIX Vector System and the predicate device are considered minor and raise no questions of safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following nonclinical tests were performed for the TACTIX Vector Syndesmosis System:
-
Cyclic fatigue testing compared against the additional predicate device (K173278)
-
Static pullout testing compared against the additional predicate device (K173278)
-
Stability testing on product packaging
-
Packaging performance testing
-
Biocompatibility evaluation per ISO 10993-1
-
Bacterial endotoxin testing
No clinical data was used used in the support of this submission.
The noncinical testing showed that the TACTIX Vector Syndesmosis System performs substantially equivalent to a predicate device. Therefore, the TACTIX Vector Syndesmosis System raises no new questions of safety or effectiveness and is substantially equivalent to the predicate devices.
21 CFR 807.92(a)(5)