ToeJack MIS Bunion System

K253423 · Nvision Biomedical Technologies, Inc. · HRS · Nov 18, 2025 · Orthopedic

Device Facts

• Record ID: K253423
• Device Name: ToeJack MIS Bunion System
• Applicant: Nvision Biomedical Technologies, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Nov 18, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ToeJack MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus.

Device Story

Single-use titanium alloy bone fixation system for hallux valgus correction; consists of plate with 4 screw-receiving holes and 3.0mm diameter locking titanium screws; includes screw targeting insertion guide. Designed for intramedullary insertion of proximal shaft with 2-screw fixation and extramedullary medial insertion of 2 distal screws. Used by orthopedic surgeons in clinical/surgical settings to stabilize osteotomies. Provides mechanical fixation to facilitate bone healing; benefits patient through corrective alignment of first metatarsal.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance evaluated via ASTM F543 (screw pullout and torsion) and static/dynamic four-point bend testing (per ASTM F382) to assess construct strength and stiffness.

Technological Characteristics

Titanium alloy bone plate and 3.0mm diameter locking titanium screws. Features 4 screw-receiving holes; designed for intramedullary and extramedullary fixation. Dimensions fall within predicate ranges. Mechanical testing performed per ASTM F543 and ASTM F382. Non-sterile or sterile (implied single-use).

Indications for Use

Indicated for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus, in patients requiring bone fixation.

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

• Radian MIS Bunion System (K211650)
• CrossRoads Extremity MIS Bunion System (K181872)
• Trilliant Surgical Minimally Invasive Bunion Plating System (K172178)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

November 18, 2025

Nvision Biomedical Technologies, Inc
Marisa Zack
In-house Counsel
4590 Lockhill Selma
San Antonio, Texas 78249

Re: K253423
Trade/Device Name: ToeJack MIS Bunion System
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulatory Class: Class II
Product Code: HRS
Dated: September 25, 2025
Received: September 25, 2025

Dear Marisa Zack:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K253423 - Marisa Zack
Page 2

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 (QS) 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/combination-products/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.

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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

{2}

K253423 - Marisa Zack
Page 3

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,

Thomas Mcnamara -S

For: Christopher Ferreira, M.S.
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

{3}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K253423

Device Name
ToeJack MIS Bunion System

Indications for Use (Describe)
The ToeJack MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus.

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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}

K253423 Page 1/2

| 510(k) Summary | | Prepared on: 2025-11-17 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Nvision Biomedical Technologies, Inc. | |
| Applicant Address | 4590 Lockhill Selma Rd. San Antonio TX 78249 United States | |
| Applicant Contact Telephone | [phone] | |
| Applicant Contact | Mrs. Marisa Zink | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | ToeJack MIS Bunion System | |
| Common Name | Plate, Fixation, Bone | |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories | |
| Regulation Number | 888.3030 | |
| Product Code(s) | HRS | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K211650 | Radian MIS Bunion System | HRS |
| K181872 | CrossRoads Extremity MIS Bunion System | HRS |
| K172178 | Trilliant Surgical Minimally Invasive Bunion Plating System | HRS |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The ToeJack MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and locking 3.0mm diameter titanium screws that provide fixation for the first metatarsal in the correction of a bunion. Specifically, the plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the proximal shaft with 2 screw fixation and extramedullary medial insertion of the 2 distal screws. Further, the device is provided with a screw targeting insertion guide. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| The ToeJack MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus. | | |
| Indications for Use Comparison | | 21 CFR 807.92(a)(5) |
| The indications for the subject device and the predicate device are the same. | | |
| Technological Comparison | | 21 CFR 807.92(a)(6) |

{5}

K253423 Page 2/2

The subject ToeJack device has the equivalent intended use/indications for use and equivalent technological characteristics as the cleared predicates. The subject device has a similar design with bone plates that can equivalently accommodate use with integrated bone screws. The subject device is manufactured from titanium alloy and titanium alloy bone screws, which is equivalent to the devices cleared in K211650 and K181872. The K172178 device incorporates equivalent features such as an angled plate, screw-receiving holes, locking screws and intramedullary fixation. The subject implant dimensions fall within the predicate ranges, including thickness, width, and length. The differences in technology characteristics include the minor differences in plate geometry and location of the bone screws.

Based on the testing performed, including static and dynamic bending, along with engineering analysis of device characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed ToeJack MIS Bunion System are assessed to be substantially equivalent to the predicate devices.

Nvision believes that the ToeJack MIS Bunion System is substantially equivalent to the predicate devices.

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

No FDA performance standards have been established for The ToeJack MIS Bunion System. The device mechanical performance was tested in accordance with recognized consensus standards and current industry practice. Engineering analysis, ASTM F543 screw pullout and torsion testing, and static and dynamic four-point bend testing (similar to ASTM F382) to evaluate construct strength and stiffness was completed to demonstrate substantial equivalence for mechanical performance.

In conclusion, non-clinical testing and analysis demonstrates that the ToeJack MIS Bunion System does not create a worst-case relative to the predicate systems and thus confirms substantial equivalence.