(14 days)
No
The provided text describes a medical implant (Cervical Spine Truss System) used for spinal fusion. There is no mention of any AI model, machine learning, or deep neural networks being part of the device's function or existence.
Yes
The device is used to treat Degenerative Disc Disease (DDD) in the cervical spine by promoting fusion and providing structural support, which are therapeutic functions.
No
The device is an interbody fusion device intended to provide structural support and facilitate bone fusion in patients with Degenerative Disc Disease (DDD). It is a therapeutic device, not a diagnostic one.
No
The device is a physical implant made of Ti6Al4V alloy, designed to provide structural support in the cervical spine. Its description details its physical characteristics, manufacturing process, and how it is used as an adjunct to fusion. It clearly describes hardware components (implant, integrated plates, screws) and their physical function (structural support, bony fixation), with no mention of software functionality as its primary or sole purpose.
No.
The device is an implantable medical device used for spinal fusion, not a diagnostic tool that examines specimens derived from the human body.
N/A
Intended Use / Indications for Use
The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. If the device is being used without the CSTS Integrated Plate, supplemental fixation must be used.
Product codes
OVE, ODP
Device Description
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of heights, footprints, and lordotic angles. The CSTS Integrated Plates come in multiple heights and orientations to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the Integrated Plates into adjacent vertebral bodies for bony fixation. The Integrated Plates have a rotating locking tab to prevent back-out of the screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine at one level or two contiguous disc levels, C2 to T1 disc levels
Indicated Patient Age Range
Skeletally mature patients
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)
The modifications made to the CSTS Integrated Plate for this submission did not create a new worst-case condition for any mechanical or MR safety tests. The results of the predicate testing are applicable to the subject devices and no further testing was required. The CSTS Integrated Plate is sufficient for its intended use and is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
FDA 510(k) Clearance Letter - Cervical Spine Truss System (CSTS)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 25, 2025
4WEB Medical
Mr. Jonathan Hires
Director of Product Development
2801 Network Blvd., Suite 620
Frisco, Texas 75034
Re: K251117
Trade/Device Name: Cervical Spine Truss System (CSTS)
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: OVE, ODP
Dated: April 10, 2025
Received: April 11, 2025
Dear Mr. Hires:
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"
Page 2
K251117 - Jonathan Hires
Page 2
(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 (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 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 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-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).
Page 3
K251117 - Jonathan Hires
Page 3
Sincerely,
Brent Showalter -S
Brent Showalter, 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
Page 4
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)
K251117
Device Name
Cervical Spine Truss System (CSTS)
Indications for Use (Describe)
The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. If the device is being used without the CSTS Integrated Plate, supplemental fixation must be used.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
Date Prepared: April 22, 2025
Contact: Jessee Hunt, President
4WEB, Inc.
2801 Network Blvd., Suite 620
Frisco, TX 75034
Phone: (800) 285-7090
Fax: 972-488-1816
Trade Name: Cervical Spine Truss System (CSTS)
Product Class: Class II
Classification: 21 CFR §888.3080
Common Name: Intervertebral Body Fusion Device
Product Codes: OVE, ODP
Panel Code: 87
Purpose:
The purpose of this submission is to add additional configurations to the integrated plate product offering and to provide the integrated plate as sterile packaged.
Indications for Use:
The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. If the device is being used without the CSTS Integrated Plate, supplemental fixation must be used.
Device Description:
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of heights, footprints, and lordotic angles. The CSTS Integrated Plates come in multiple heights and orientations to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the Integrated Plates into adjacent vertebral bodies for bony fixation. The Integrated Plates have a rotating locking tab to prevent back-out of the screws.
K251117
Page 1 of 2
Page 6
K251117
Page 2 of 2
Predicate Device(s):
The primary predicate device is the 4WEB Medical Cervical Spine Truss System (K231739). An additional reference predicate is the 4WEB Medical Lateral Spine Truss System Plating Solution (K203065).
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.
Performance Standards:
The modifications made to the CSTS Integrated Plate for this submission did not create a new worst-case condition for any mechanical or MR safety tests. The results of the predicate testing are applicable to the subject devices and no further testing was required. The CSTS Integrated Plate is sufficient for its intended use and is substantially equivalent to the legally marketed predicate device.
Conclusion:
4WEB, Inc. concludes that the CSTS devices are substantially equivalent to the predicate devices and raise no new questions of safety and effectiveness.