TACTIX Vector Syndesmosis System

K243408 · Vilex, LLC · HTN · Nov 27, 2024 · Orthopedic

Device Facts

• Record ID: K243408
• Device Name: TACTIX Vector Syndesmosis System
• Applicant: Vilex, LLC
• Product Code: HTN · Orthopedic
• Decision Date: Nov 27, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 TACTIX 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.

Device Story

System provides syndesmotic fixation during healing; utilizes suture loop and buttons. Features tensioner for suture tensioning; line lock technology eliminates knot tying. Requires minimal medial skin nick; creates small bone thru-hole for 2.0 mm suture loop. Used by surgeons in clinical settings; can be used with Vilex fibular bone plates and screws. Provides stable fixation; benefits patient by facilitating healing of syndesmotic disruptions.

Clinical Evidence

No clinical data was required. Substantial equivalence supported by bench testing, including mechanical performance engineering analysis, steam sterilization validation, and biological evaluation. All results met acceptance criteria.

Technological Characteristics

Metallic bone fixation system consisting of suture loops, buttons, tensioner, and washer. Features line lock suture technology. Connectivity: N/A. Sterilization: Steam sterilization. Materials: Metallic components.

Indications for Use

Indicated for patients requiring fixation during healing of syndesmotic trauma, including syndesmosis disruptions associated with Weber B and C ankle fractures; also indicated as an adjunct for metaphyseal/periarticular small bone fragment fracture repair where screws are not indicated, and as an adjunct for external/intramedullary fixation systems.

Regulatory Classification

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.

Predicate Devices

• TACTIX Vector Syndesmosis System (K240035)

Reference Devices

• Alphalok Plating System (K230204)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 27, 2024

Vilex LLC Brock Johnson President 111 Moffitt Street McMinnville, Tennessee 37110

Re: K243408

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: October 31, 2024 Received: November 1, 2024

Dear Brock 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/cdrh/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.

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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).

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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/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/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## CHRISTOPHER EERREIRA -S

Christopher Ferreira, MS Assistant Director DHT6B: 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

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### Indications for Use

Submission Number (if known)

K243408

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 TACTIX 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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| 510(k) #: | K243408 | | 510(k) Summary | | Prepared on: 2024-10-31 |
|-----------|---------|--|----------------|--|-------------------------|
|-----------|---------|--|----------------|--|-------------------------|

Contact Details

| Applicant Name | Vilex LLC |
|-----------------------------|-------------------------------------------------------|
| Applicant Address | 111 Moffitt Street McMinnville TN 37110 United States |
| Applicant Contact Telephone | [phone] |
| Applicant Contact | Mr. Brock Johnson |
| Applicant Contact Email | [e-mail] |

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(s) | HTN |

Legally Marketed Predicate Devices

| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|-------------|----------------------------------------------------------|--------------|
| K240035 | TACTIX Vector Syndesmosis System | HTN |
| K230204 | Alphalok Plating System (reference device) | HRS |

Device Description Summary
The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following 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 skin nick, a larger 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

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 TACTIX 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.

# Indications for Use Comparison

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(5)

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The indications for use of the subject device are identical to the indications for use of the primary predicate device.

# Technological Comparison

21 CFR 807.92(a)(6)

There have been no change to the TACTIX Vector Syndesmosis System device classifications for use, principles of operation, manufacturing materials, or basic device device adds the option for non-sterile delivery of the TACTIX Vector Medial Buttons and Tensioner. The subject device also adds the TACTIX Vector Washer for use with the system.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

No clinical data was required in support of the subject device.

The following non-clinical tests and analyses were performed to demonstrate of the subject device with the predicate device:

- Steam sterilization validation

- Engineering analysis of mechanical performance
- Biological evaluation

All results met the acceptance criteria. Therefore, the subject device is substantially equivalent to the predicate device.