(159 days)
No
The 510(k) summary describes a mechanical fixation system for ankle syndesmosis repair and does not mention any AI or ML components or functionalities.
Yes
The device is intended to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture, which is a therapeutic purpose.
No
The device is a surgical fixation system intended to provide mechanical support for fracture repair, not to diagnose a condition.
No
The device description clearly states that the Bolo Button System consists of physical components made of titanium alloy and suture tape, along with associated instrumentation like drill bits and inserters. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Bolo Button System is to provide mechanical fixation for fracture repair in the ankle. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device consists of implants (buttons and suture tape) and surgical instruments used to place these implants. These are physical devices used in a surgical procedure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
The Bolo Button System does not involve the examination of specimens from the body. It is a device used within the body to provide structural support during healing.
N/A
Intended Use / Indications for Use
The Bolo Button System is intended to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.
Product codes
HTN
Device Description
The Bolo Button System consists of two syndesmosis buttons made of titanium alloy (Ti6AI4V ELI (ASTM F136)) and suture tape (Ultra High Molecular Weight Polyethylene Suture (UHMWPE) (ASTM F2848)). It is intended for fixation of syndesmotic injuries in an ankle fracture. The system offers two lateral button sizes. One fits 1.5mm suture tape and the other fits 2.0mm suture tape. Both share the same medial button. System instrumentation includes: drill bits, K-wires, tissue protector, and an inserter which deploys the implants. The implants and associated instrumentation are supplied sterile. This is a single use system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle
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
No clinical studies were performed. Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering rational along with static and dynamic testing was performed to show substantial performance equivalence. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified above.
Key Metrics
Not Found
Predicate Device(s)
Smith & Nephew, Inc.: INVISIKNOT Ankle Syndesmosis Repair Kit (K162996), Arthrex, Inc.: TightRope™ II (K202581), Zimmer Biomet, Inc.: ZipTight™ Ankle Fixation System (K130033)
Reference Device(s)
Fusion Orthopedics USA, LLC: PolyLock Plating System (K211843)
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.
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December 23, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and 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.
Fusion Orthopedics Catalina Pardo Quality Engineer 6859 E Rembrandt Ave Suite 122 Mesa, Arizona 85212
Re: K242091
Trade/Device Name: Bolo Button 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: December 3, 2024 Received: December 3, 2024
Dear Catalina Pardo:
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.
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"
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(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 OS 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 Rue"). 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-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 mediation-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-regulatoryassistance/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).
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Sincerely,
Digitally signed by RYAN RYAN TROMBETTA -S TROMBETTA -S Date: 2024.12.23 13:08:16 -05'00'
For: Limin Sun, Ph.D. Assistant Director
DHT6A: Division of Joint Arthroplasty 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
Form Approved: 0MB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
| K242091
Device Name
Bolo Button System
Indications for Use (Describe)
The Bolo Button System is intended to provide fixation as an adjunct to fracture repair hardware during the healing period following an anklle syndesmotic trauma with fracture.
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) Summary: Bolo Button System
| Date Prepared | December 19th, 2024 |
|---|---|
| Submitted By | Fusion Orthopedics USA, LLC |
| 6859 E. Rembrandt Ave., Suite 122 | |
| Mesa, AZ 85212 | |
| 800-403-6876 | |
| Primary Contact | Eli Jacobson |
| 6859 E. Rembrandt Ave., Suite 122 | |
| Mesa, AZ 85212 | |
| 800-403-6876 Tele | |
| e-mail: eli@fusionorthopedics.com | |
| Trade Name | Bolo Button System |
| Common Name | Soft Tissue Fixation Device |
| Class | II |
| Product Code | HTN |
| Regulation | 21 CFR Section 888.3030 – Single/multiple component metallic bone fixation |
| appliances and accessories. | |
| Device Panel | Orthopedic |
| Predicate Devices | Primary Predicate: |
| Smith & Nephew, Inc.: INVISIKNOT Ankle Syndesmosis Repair Kit (K162996) | |
| Additional Predicates: | |
| Arthrex, Inc.: TightRope™ II (K202581) | |
| Zimmer Biomet, Inc.: ZipTight™ Ankle Fixation System (K130033) | |
| Reference Device: | |
| Fusion Orthopedics USA, LLC: PolyLock Plating System (K211843) | |
| Device | |
| Description | The Bolo Button System consists of two syndesmosis buttons made of titanium alloy |
| (Ti6AI4V ELI (ASTM F136)) and suture tape (Ultra High Molecular Weight Polyethylene | |
| Suture (UHMWPE) (ASTM F2848)). | |
| It is intended for fixation of syndesmotic injuries in an ankle fracture. | |
| The system offers two lateral button sizes. One fits 1.5mm suture tape and the other fits | |
| 2.0mm suture tape. Both share the same medial button. | |
| System instrumentation includes: drill bits, K-wires, tissue protector, and an inserter which | |
| deploys the implants. The implants and associated instrumentation are supplied sterile. This | |
| is a single use system. | |
| Indications for | |
| Use | The Bolo Button System is intended to provide fixation as an adjunct to fracture repair |
| hardware during the healing period following an ankle syndesmotic trauma with fracture. | |
| Materials | Titanium Alloy Ti6Al4V ELI (ASTM F136) |
| Stainless Steel (ASTM F899) | |
| Ultra-High Molecular Weight Polyethylene Suture (UHMWPE) (ASTM F2848) | |
| Comparison of | |
| Technological | |
| Characteristics | The Bolo Button System and the predicate devices implants' are manufactured from |
| titanium alloy (ASTM F136) are compatible with similar sized buttons, have similar widths, | |
| thickness, lengths, and designs/shapes. The suture tape which binds both buttons in the | |
| Bolo Button System is also used in the predicate device. Systems are equivalent in their | |
| features and in intended use. | |
| Non-clinical Test | |
| Summary | Validations were performed on the cleaning, packaging and sterilization of the implants and |
| associated surgical instruments. Engineering rational along with static and dynamic testing | |
| was performed to show substantial performance equivalence. The results of the testing | |
| demonstrate that the device is substantially equivalent to the predicate device identified | |
| above. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: | |
| Non- clinical and | |
| Clinical | Fusion Orthopedics USA, LLC considers the Bolo Button System to be equivalent to the |
| predicate devices listed above. This conclusion is based upon the devices' similarities in | |
| principles of operation, technology, materials, and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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