(105 days)
No
The summary describes a mechanical implant for hammertoe correction and does not mention any AI/ML components or functions.
Yes
The device is indicated for fixation of osteotomies and reconstruction of lesser toes following correctional procedures, which constitutes addressing a medical condition.
No
Explanation: The device, the Hammertoe Truss System (HTS), is described as a system for the "fixation of osteotomies and reconstruction of the lesser toes" and provides "stability and fixation of the lesser toes in the foot." It is an implant designed to provide structural support, not to diagnose medical conditions or diseases. Its function is interventional/therapeutic, not diagnostic.
No
The device description explicitly states that the device consists of "a series of titanium implants" which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe." This describes a surgical implant used in vivo (within the body) for structural support and fixation.
- Device Description: The description details titanium implants designed to provide "stability and fixation of the lesser toes in the foot." This further reinforces its role as a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
Therefore, the Hammertoe Truss System (HTS) is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hammertoe Truss System (HTS) is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the Hammertoe Truss System (HTS) can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser toes in the foot
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)
Performance testing has been completed per the following standards: ASTM F1264 – Static and Dynamic 3-Point Bend and Torque to Failure ASTM F543 – Axial Push Out
MR Conditional testing listed below is from the primary predicate device, the 4WEB CSTS Cervical Spine Truss System (K173159). The Hammertoe Truss System does not present a new worst case. ASTM F2119 — MR Image Artifact ASTM F2052 - MR Induced Displacement Force ASTM F2213 – MR Induced Torque ASTM F2182 – MR Induces Heating
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.
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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July 23, 2019
4WEB, Inc. % Rich Jansen, Pharm.D. Silver Pine Consulting, LLC 3851 Mossy Oak Drive Ft. Myers, Florida 33905
Re: K190926
Trade/Device Name: Hammertoe Truss System (HTS) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: July 3, 2019 Received: July 5, 2019
Dear Dr. Jansen:
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 (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 located 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.
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 803) for
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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Ronald P. Jean, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known) K190926
Device Name Hammertoe Truss System (HTS)
Indications for Use (Describe)
The Hammertoe Truss System (HTS) is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the Hammertoe Truss System (HTS) can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
| 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
| Date Prepared: | April 9, 2019 |
|---|---|
| Contact: | Jessee Hunt, President |
| 4WEB, Inc. | |
| 2801 Network Blvd., Suite 620 | |
| Frisco, TX 75034 | |
| Phone: (800) 285-7090 | |
| Fax: 972-488-1816 | |
| Regulatory Contact: | Rich Jansen, Pharm. D. |
| Silver Pine Consulting, LLC | |
| richj@s-pineconsulting.com | |
| Trade Name: | Hammertoe Truss System (HTS) |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3040 |
| Common Name: | Smooth or threaded metallic bone fixation fastener |
| Product Codes: | HTY |
| Panel Code: | 87 |
Indications for Use:
The Hammertoe Truss System (HTS) is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the Hammertoe Truss System (HTS) can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
Device Description:
The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.
Predicate Device(s):
The primary predicate device is the Additive Orthopaedics Hammertoe Correction System (K160264). Additional predicates include the Wright Medical PRO-TOE Hammertoe Fixation System (K151838).
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Performance Standards:
Performance testing has been completed per the following standards: ASTM F1264 – Static and Dynamic 3-Point Bend and Torque to Failure ASTM F543 – Axial Push Out
MR Conditional testing listed below is from the primary predicate device, the 4WEB CSTS Cervical Spine Truss System (K173159). The Hammertoe Truss System does not present a new worst case. ASTM F2119 — MR Image Artifact ASTM F2052 - MR Induced Displacement Force ASTM F2213 – MR Induced Torque ASTM F2182 – MR Induces Heating
Technological Characteristics:
4Web Medical, Inc. has compared this device to the previously cleared predicate devices in regards to indications for use, materials, function, sizes and mechanical test results. These comparisons demonstrate substantial equivalence to the predicate devices.
Conclusion:
4WEB Medical, Inc. concludes that the Hammertoe Truss System is substantially equivalent to the predicate devices.