(267 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any AI or ML components or functionalities.
No
A therapeutic device is one that performs its action (e.g., healing a fracture) through its own inherent means. The Osteotomy Truss System (OTS) is an internal bone fixation device that supports healing, but the healing itself is a biological process of the patient, not an action performed by the device. The device provides mechanical support while the body heals, but it does not actively participate in the therapeutic process itself beyond providing structural support.
No
The device, the Osteotomy Truss System (OTS), is described as an implant for internal bone fixation for fractures or osteotomies in the foot, providing structural support for bone growth and fusion. Its function is to treat, not diagnose, medical conditions.
No
The device description explicitly states that the device consists of "five implant designs" made from "Ti6Al4V alloy," 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 "internal bone fixation for bone fractures or osteotomies in the foot." This is a surgical implant used directly on the patient's body.
- Device Description: The description details a physical implant made of Ti6Al4V alloy, designed for structural support and bone growth.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The Osteotomy Truss System (OTS) is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- Metatarsal/Cuneiform osteotomies
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
- Hindfoot osteotomies
The device is intended for use with supplemental fixation.
The Osteotomy Truss System is not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Osteotomy Truss System (OTS) consists of five implant designs in a variety of footprints and implant height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixation.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Engineering analysis, static axial compression testing per ASTM F2077, and dynamic axial compression testing per ASTM F2077 demonstrated that the product line extension for the Osteotomy Truss System (OTS) does not introduce a new worst-case compared to the previously cleared 4WEB Osteotomy Truss System devices for mechanical properties of the device.
Performance testing has been completed per the following standards for the combined Osteotomy Truss System (OTS):
- Static axial compression per ASTM F2077
- Dynamic axial compression fatigue per ASTM F2077
- Expulsion testing per ASTM F-04.25.02.02
- MR image artifact per ASTM F2119
- MR induced heating per ASTM F2182
- MR induced torque per ASTM F2213
- MR induced displacement force per ASTM F2052
The results of this non-clinical testing show that the strength of the OTS Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
Not Found
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
§ 888.3030 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.
0
Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 1, 2024
4WEB Medical, Inc. % Richard Jansen Consultant Silver Pine Consulting 3851 Mossy Oak Drive Fort Myers, Florida 33905
Re: K240388
Trade/Device Name: Osteotomy Truss System (OTS) 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: October 1, 2024 Received: October 1, 2024
Dear Richard 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 (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.
1
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 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.
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-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
2
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,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, MS 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Osteotomy Truss System (OTS)
Indications for Use (Describe)
The Osteotomy Truss System (OTS) is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus .
- . Opening wedge of Medial Cuneiform or Cotton osteotomies
- . Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- . Metatarsal/Cuneiform osteotomies
- . Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
- . Hindfoot osteotomies
The device is intended for use with supplemental fixation.
The Osteotomy Truss System is not intended for use in the spine.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(k) Summary
| Date Prepared:
Contact: | September 30th, 2024
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: | Osteotomy Truss System (OTS) |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3030 |
| Common Name: | Single/Multiple Component Metallic Bone Fixation Appliances and
Accessories |
| Product Codes: | HRS |
| Panel Code: | 87 |
Purpose:
The purpose of this submission is to update the Osteotomy Truss System (OTS) implant offering.
Indications for Use:
The Osteotomy Truss System (OTS) is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- . Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- Metatarsal/Cuneiform osteotomies
- . Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
- . Hindfoot osteotomies
The device is intended for use with supplemental fixation.
The Osteotomy Truss System is not intended for use in the spine.
5
Device Description:
The Osteotomy Truss System (OTS) consists of five implant designs in a variety of footprints and implant height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixation.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.
Predicate Device(s):
The primary predicate device is the 4WEB Medical Osteotomy Truss System (K220463).
Performance Standards:
Engineering analysis, static axial compression testing per ASTM F2077, and dynamic axial compression testing per ASTM F2077 demonstrated that the product line extension for the Osteotomy Truss System (OTS) does not introduce a new worst-case compared to the previously cleared 4WEB Osteotomy Truss System devices for mechanical properties of the device.
Performance testing has been completed per the following standards for the combined Osteotomy Truss System (OTS):
- Static axial compression per ASTM F2077
- Dynamic axial compression fatigue per ASTM F2077
- Expulsion testing per ASTM F-04.25.02.02
- MR image artifact per ASTM F2119
- MR induced heating per ASTM F2182
- MR induced torque per ASTM F2213
- . MR induced displacement force per ASTM F2052
The results of this non-clinical testing show that the strength of the OTS Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Technological Characteristics:
4WEB, Inc. has compared these devices to the previously cleared predicate devices in regard to indications for use, materials, function, sizes and simulated testing. These comparisons demonstrate substantial equivalence to the predicate devices.
Conclusion:
4WEB, Inc. concludes that the OTS device is substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.