(434 days)
No
The summary describes a mechanical implant and its intended use, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is a permanently implanted system designed to provide mechanical support and facilitate fusion in a salvage procedure, which directly addresses a medical condition (failed ankle arthrodesis or failed ankle arthroplasty) to restore function and prevent limb loss.
No
The device is described as an implanted system designed to provide mechanical support and facilitate fusion in the tibiotalocalcaneal joint. Its purpose is to physically aid in a salvage procedure, not to diagnose a condition.
No
The device description explicitly states the device is a "permanently implanted device" made of "titanium alloy (Ti6Al4V) structures," indicating it is a physical hardware implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The 4WEB Medical Ankle Truss System (ATS) is described as a permanently implanted device made of titanium alloy. It is intended to provide mechanical support as an accessory to a surgical nail for bone fusion.
- Intended Use: The intended use is for a surgical procedure (tibiotalocalcaneal fusion) within the body, not for testing samples outside the body.
- Input: The input is described as "appropriate radiography scans," which are imaging modalities used to visualize structures within the body, not samples for laboratory testing.
The device is clearly an implantable surgical device used to aid in bone fusion, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 4WEB Medical Ankle Truss System (ATS) is for use as an accessory to the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk for loss of limb. The ATS is not intended for standalone use.
The anatomical landmarks necessary for the design and creation of ATS devices that are patient matched must be present and identifiable on appropriate radiography scans. The ATS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Product codes (comma separated list FDA assigned to the subject device)
SAI, HSB
Device Description
The 4WEB Medical Ankle Truss System (ATS) is a permanently implanted device intended to provide mechanical support as an accessory to a tibiotalocalcaneal nail intended to fuse the tibiotalocalcaneal joint in a salvage procedure following a failed ankle arthrodesis or a failed ankle arthroplasty for patients at risk for loss of limb. ATS devices are titanium alloy (Ti6Al4V) structures in spherical or cuboidal configurations. The ATS device has an open architecture truss designed to provide structural support with open space throughout the implant to allow fusion. ATS devices are intended for use with the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal (TTC) fusion system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiography scans
Anatomical Site
tibiotalocalcaneal joint
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Evaluation:
- Static and dynamic testing per ASTM F2077 (With and Without an IM Nail) followed by testing per ASTM F1264
- Corrosion Assessment
- Wear Assessment
Clinical Performance Evaluation:
- a retrospective, single arm, multi-center evaluation of the ATS device. Control treatments were an IM nail for TTC fusion for failed total ankle arthrodesis patients. Effectiveness endpoints included fusion, pain, and functional outcomes for the subject and control treatments. Safety outcomes included analysis of device and procedure related adverse events and rates of subsequent secondary surgical intervention (SSSI) for the subject and control treatments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Stryker Valor Hindfoot Fusion Nail (K090857), Stryker T2 Ankle Arthrodesis Nail (K200880)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
4WEB Medical Lateral Spine Truss System - Interbody Fusion Device (K211388)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
March 21, 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
4WEB Medical, Inc. % Kathy Herzog Regulatory Consultant DuVal & Associates, P.A. 1820 Medical Arts Building 825 Nicollet Mall Minneapolis. Minnesota 55402
Re: K230088
Trade/Device Name: Ankle Truss System (ATS) Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: SAI, HSB Dated: March 19, 2024 Received: March 20, 2024
Dear Kathy Herzog:
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" (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
1
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 (OS) 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.
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-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).
Sincerely.
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2024.03.21
15:03:45 -04'00'
Farzana Sharmin, PhD 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
2
Indications for Use
510(k) Number (if known) K230088
Device Name Ankle Truss System (ATS)
Indications for Use (Describe)
The 4WEB Medical Ankle Truss System (ATS) is for use as an accessory to the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk for loss of limb. The ATS is not intended for standalone use.
The anatomical landmarks necessary for the design and creation of ATS devices that are patient matched must be present and identifiable on appropriate radiography scans. The ATS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
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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3
510(k) Summary
| Date Prepared: | March 21, 2024 |
|---|---|
| Contact: | Jarod Oldham, VP of Quality and Regulatory |
| 4WEB Medical, Inc. | |
| 2801 Network Blvd., Suite 620 | |
| Frisco, TX 75034 | |
| Phone: (800) 285-7090 | |
| Fax: 972-488-1816 | |
| Regulatory Contact: | Kathy Herzog, Sr. Regulatory, Quality, & Compliance Consultant |
| DuVal & Associates, PA | |
| herzog@duvalfdalaw.com | |
| Trade Name: | Ankle Truss System (ATS) |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3020 |
| Common Name: | Rod, Fixation, Intramedullary and Accessories |
| Product Code: | SAI |
| Secondary Product Code: | HSB |
Predicate Device(s):
The primary predicate device is the Stryker Valor Hindfoot Fusion Nail (K090857). An additional predicate is the Stryker T2 Ankle Arthrodesis Nail (K200880). A reference device is the 4WEB Medical Lateral Spine Truss System - Interbody Fusion Device (K211388).
Device Description:
The 4WEB Medical Ankle Truss System (ATS) is a permanently implanted device intended to provide mechanical support as an accessory to a tibiotalocalcaneal nail intended to fuse the tibiotalocalcaneal joint in a salvage procedure following a failed ankle arthrodesis or a failed ankle arthroplasty for patients at risk for loss of limb. ATS devices are titanium alloy (Ti6Al4V) structures in spherical or cuboidal configurations. The ATS device has an open architecture truss designed to provide structural support with open space throughout the implant to allow fusion. ATS devices are intended for use with the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal (TTC) fusion system.
Indications for Use:
The 4WEB Medical Ankle Truss System (ATS) is for use as an accessory to the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk for loss of limb. The ATS is not intended for standalone use.
The anatomical landmarks necessary for the design and creation of ATS devices that are patient matched must be present and identifiable on appropriate radiography scans. The ATS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
4
Subject and Predicate Device Comparison
Both the subject and predicate devices have the same intended use for tibiotalocalcaneal (TTC) fusion. The indications for use of the ATS are a subset of the indications for use for the predicate Stryker Valor Hindfoot Fusion Nail, K090857.
The technological characteristics of the ATS device differ from the predicate device. The materials, truss design, and manufacturing of the ATS are similar to the reference device (K211388). Both the subject device and reference device are made of titanium alloy (Ti6Al4V) and are manufactured using an identical additive manufacturing technique.
Non-Clinical Performance Evaluation
The following non-clinical performance testing has been completed on the subject device:
- Static and dynamic testing per ASTM F2077 (With and Without an IM Nail) followed by testing per ASTM F1264
- Corrosion Assessment
- Wear Assessment
Clinical Performance Evaluation
4WEB Medical completed a retrospective, single arm, multi-center evaluation of the ATS device. Control treatments were an IM nail for TTC fusion for failed total ankle arthrodesis patients. Effectiveness endpoints included fusion, pain, and functional outcomes for the subject and control treatments. Safety outcomes included analysis of device and procedure related adverse events and rates of subsequent secondary surgical intervention (SSSI) for the subject and control treatments.
Conclusion
The nonclinical and clinical performance testing demonstrate that the subject device is substantially equivalent to the predicate device, Stryker Valor Hindfoot Fusion Nail (K090857), when used as intended.