enHAnce PEEK Bunion System
Device Facts
| Record ID | K253718 |
|---|---|
| Device Name | enHAnce PEEK Bunion System |
| Applicant | Nvision Biomedical Technologies, Inc. |
| Product Code | HRS · Orthopedic |
| Decision Date | Apr 1, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The enHAnce PEEK 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 bone fixation system for hallux valgus correction; consists of HA-enhanced PEEK plate and 3.0mm cannulated pins. Implanted via intramedullary insertion of plate stem into first metatarsal; secured with distal pins (medial insertion) and proximal pin (shaft fixation). Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical stability for bone healing post-osteotomy. Benefits patient through permanent fixation of corrective bunion procedures.
Clinical Evidence
Bench testing only. No clinical data provided. Mechanical performance evaluated via static and fatigue four-point bending tests per ASTM F382-24, pushout tests, and axial insertion tests. Engineering analysis confirms performance is not a worst-case relative to predicate systems.
Technological Characteristics
Materials: HA-enhanced PEEK. Design: Cannulated plate with stem and pin-receiving holes; 3.0mm diameter pins. Fixation: Intramedullary. Standards: ASTM F382-24 (four-point static and fatigue bend testing). Sterilization: Not specified.
Indications for Use
Indicated for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus.
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)
- Novastep Airlock Osteosynthesis Implant System (K192356)
- CrossRoads MINIBunion System (K190658)
- Impact PEEK Union Nail (K250646)
- Biomet Kirschner Wires (K-Wires) (K241014)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 1, 2026
Nvision Biomedical Technologies, Inc.
Marisa Zink
In-House Counsel
4590 Lockhill Selma Rd.
San Antonio, Texas 78249
Re: K253718
Trade/Device Name: enHAnce PEEK 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: March 10, 2026
Received: March 11, 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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 the DICE website (https://www.fda.gov/medical-devices/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thomas Mcnamara -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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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)
K253718
Device Name
enHAnce PEEK Bunion System
Indications for Use (Describe)
The enHAnce PEEK 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)
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510(k) #: K253718
510(k) Summary
Prepared on: 2026-03-29
# 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 | 2108706261 |
| Applicant Contact | Mrs. Marisa Zink |
| Applicant Contact Email | marisazink@nvisionbiomed.com |
# Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | enHAnce PEEK Bunion 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 |
# 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 |
| K192356 | Novastep Airlock Osteosynthesis Implant System | HRS |
| K190658 | CrossRoads MINIBunion System | HRS |
| K250646 | Impact PEEK Union Nail | HTY |
| K241014 | Biomet Kirschner Wires (K-Wires) | HTY |
# Device Description Summary
21 CFR 807.92(a)(4)
The enHAnce PEEK Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a plate and 3.0mm diameter pins that provide fixation for the first metatarsal in the correction of a bunion. The plate and pins are manufactured from HA Enhanced PEEK, are cannulated, and allow for intramedullary insertion and fixation at the proximal end. The plate has four pin-receiving holes with a stem portion. It is designed to allow for intramedullary insertion of the stem portion and fixation via the pins at the distal end. The three distal pins allow for medial insertion and the one proximal pin allows for metatarsal shaft fixation
# Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The enHAnce PEEK 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)
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The indications for the subject device and the predicate device are the same.
## Technological Comparison
21 CFR 807.92(a)(6)
The subject enHAnce Bunion 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 pins. The subject device is manufactured from HA enhanced PEEK and HA enhanced PEEK pins, which is equivalent to the devices cleared in K211650, K250646, and K192356. The K211650 and K192356 devices incorporate equivalent features such as an angled plate or plate and stem, screw or pin-receiving holes, and intramedullary fixation. The K250646 device incorporates equivalent features such as the HA enhanced PEEK material and the cylindrical stem for fixation. The subject implant dimensions fall within the predicate ranges, including thickness, width, and length.
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 enHAnce PEEK Bunion System are assessed to be substantially equivalent to the predicate devices.
Nvision believes that the enHAnce PEEK 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 enHAnce PEEK Bunion System. The device mechanical performance was tested in accordance with recognized consensus standards and current industry practice. ASTM F382-24 four-point static and fatigue bend testing was conducted against the predicates. Engineering analysis, static and dynamic bending, pushout and axial insertion tests were completed for a substantial equivalence determination.
Engineering analysis demonstrates that the enHAnce PEEK Bunion System does not create a worst-case relative to the predicate systems and thus confirms substantial equivalence with respect to mechanical performance.
