Vortex5 Tailor's Bunion Correction System

K260291 · Nvision Biomedical Technologies, Inc. · HRS · Mar 25, 2026 · Orthopedic

Device Facts

• Record ID: K260291
• Device Name: Vortex5 Tailor's Bunion Correction System
• Applicant: Nvision Biomedical Technologies, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 25, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vortex5 Tailor's Bunion Correction System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the toes (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent patients (13-21 years of age).

Device Story

Bone fixation system for 5th metatarsal osteotomies; consists of additively manufactured titanium alloy plate and machined screws; intended for permanent implantation. Used by orthopedic surgeons in clinical settings to stabilize bone segments following surgical correction of Tailor's Bunion. Provides mechanical fixation to support bone healing and reconstruction. Benefits patient by restoring foot anatomy and function.

Clinical Evidence

Bench testing only. Performance verified through engineering analysis, static and dynamic bending, pullout, and shear tests in accordance with consensus standards and industry practice. No clinical data presented.

Technological Characteristics

Additively manufactured titanium alloy plate; machined screws. Features include screw-receiving holes, tapered ends, and locking mechanisms. Dimensions (diameter, thickness, width, length) within predicate ranges. Single-use, permanently implanted.

Indications for Use

Indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the toes, specifically 5th metatarsal osteotomies for Tailor's Bunion correction. Applicable to adults and adolescents (13-21 years).

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

• Javelin Tailor's Bunion Fixation System (K202657)

Reference Devices

• K182949
• K171558

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

March 25, 2026

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

Re: K260291
Trade/Device Name: Vortex5 Tailor's Bunion Correction 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, HWC
Dated: January 29, 2026
Received: January 29, 2026

Dear Marisa Zink:

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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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

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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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 FERREIRA -S

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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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. |
| --- | --- |
| 510(k) Number (if known) K260291 | |
| Device Name Vortex5 Tailor's Bunion Correction System | |
| Indications for Use (Describe) The Vortex5 Tailor's Bunion Correction System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the toes (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent patients (13-21 years of age). | |
| 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." | |

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| 510(k) Summary | | Prepared on: 2026-03-24 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Nvision Biomedical Technologies, Inc. | |
| Applicant Address | 4590 Lockhill Selma Road San Antonio TX 78249 United States | |
| Applicant Contact Telephone | 210-870-6261 | |
| Applicant Contact | Mrs. Marisa Zink | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Vortex5 Tailor's Bunion Correction System | |
| Common Name | Single/multiple component metallic bone fixation appliances and accessories | |
| Classification Name | Plate, Fixation, Bone | |
| Regulation Number | 888.3030 | |
| Product Code(s) | HRS, HWC (CLASS 2) | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K202657 | Javelin Tailor's Bunion Fixation System | HRS |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Vortex 5 Tailor's Bunion Correction System is a single-use bone Correction device intended to be permanently implanted. The system consists of an additively manufactured titanium alloy plate and machined screws that provide correction for 5th metatarsal osteotomies for the correction of Tailor's Bunion. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| The Vortex5 Tailor's Bunion Correction System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the toes (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent patients (13-21 years of age). | | |
| 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) |
| The subject device has a similar design, similar dimensions, and uses similar or identical materials as the devices cleared in K202657, K182949, and K171558. The subject device also has the same intended use, as well as similar technological characteristics as these predicates. The Indications for Use are equivalent and any minor differences in wording choices are insignificant. These technological characteristics have undergone testing and engineering analysis to ensure the device is as safe and effective as the predicates. Further, the subject plates and screws incorporate equivalent features such as screw-receiving holes, tapered end, and locking screws. The | | |

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subject implant dimensions fall within the predicate ranges, including diameter, thickness, width, and length.

Based on the testing performed, including static and dynamic bending, static torsion, and 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 Vortex5 Tailor's Bunion Correction System are assessed to be substantially equivalent to the predicate devices.

Nvision believes that the Vortex5 Tailor's Bunion Correction 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 Vortex5 Tailor's Bunion Correction System. The device mechanical performance was tested in accordance with recognized consensus standards and current industry practice. Engineering analysis, static and dynamic bending, pullout and shear tests were completed for a substantial equivalence determination.

Engineering analysis demonstrates that the Vortex5 Tailor's Bunion Correction System does not create a worst-case relative to the predicate systems and thus confirms substantial equivalence with respect to mechanical performance.