Sacroiliac Joint Truss System (SJTS)

K252834 · 4Web Medical · OUR · Jan 28, 2026 · Orthopedic

Device Facts

Record IDK252834
Device NameSacroiliac Joint Truss System (SJTS)
Applicant4Web Medical
Product CodeOUR · Orthopedic
Decision DateJan 28, 2026
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3040
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Sacroiliac Joint Truss System is indicated for sacroiliac joint fusion for: - Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. - Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The Sacroiliac Joint Truss System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

Device Story

SJTS is a surgical system for sacroiliac joint fusion and pelvic fracture fixation; comprises cannulated, fenestrated threaded implants and instrument set. Implants are Ti6Al4V alloy; available as fully threaded compression screws or partially threaded lag screws with washers. Used in clinical settings by surgeons; intended for use with autograft or allogenic bone graft. Provides mechanical stabilization of the sacroiliac joint or pelvic fractures. Surgeon selects appropriate diameter/length based on patient anatomy; implants are placed to facilitate fusion or fracture healing. Benefits include joint immobilization and structural support for pelvic/spinal stability.

Clinical Evidence

Bench testing only. Testing included static/dynamic cantilever bending, axial pullout, static torsion, and driving torque per ASTM F3574. MR compatibility testing performed per ASTM F2119, F2182, F2213, and F2051. Results demonstrate sufficient strength and substantial equivalence to predicates.

Technological Characteristics

Materials: Ti6Al4V alloy. Design: Cannulated, fenestrated threaded implants (fully threaded or partially threaded lag screws with washers). Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified (referenced existing 4Web cleaning/sterilization family). Standards: ASTM F3574 (mechanical), ASTM F2119, F2182, F2213, F2051 (MR safety).

Indications for Use

Indicated for skeletally mature patients requiring sacroiliac joint fusion due to dysfunction (disruption, degenerative sacroiliitis), stabilization during sacropelvic fixation (lumbar/thoracolumbar fusion), or pelvic fracture fixation (acute, non-acute, nontraumatic).

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION January 28, 2026 4Web Medical Jonathan Hires Director, Product Development 2801 Network Blvd. Suite 620 Frisco, Texas 75034 Re: K252834 Trade/Device Name: Sacroiliac Joint Truss System (SJTS) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR, HWC Dated: September 5, 2025 Received: December 29, 2025 Dear Jonathan 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252834 - Jonathan Hires Page 2 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 (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- {2} K252834 - Jonathan Hires Page 3 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). Sincerely, # STEPHANIE SMITH -S For Colin O'Neill, M.B.E. 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 {3} 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) K252834 Device Name Sacroiliac Joint Truss System (SJTS) Indications for Use (Describe) The Sacroiliac Joint Truss System is indicated for sacroiliac joint fusion for: - Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. - Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The Sacroiliac Joint Truss System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures. 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." {4} K252834 Page 1 of 2 510(k) Summary Date Prepared: December 29th, 2025 Contact: Jonathan Hires, Director of Product Development 4Web Medical 2801 Network Blvd., Suite 620 Frisco, TX 75034 Phone: (800) 285-7090 Fax: 972-488-1816 Trade Name: Sacroiliac Joint Truss System (SJTS) Product Class: Class II Classification: 21 CFR §888.3040 Common Name: Sacroiliac Joint Fixation Product Codes: OUR, HWC Predicate Device(s): The primary predicate device is the SI-BONE iFuse-TORQ Implant System (K222605). The additional predicate device is the SI-BONE iFuse Bedrock Granite Implant System (K220195). Reference predicates for this submission are the 4Web Medical Lateral Spine Truss System Plating Solution (K203065). Device Description: The SJTS is a comprehensive surgical solution for sacroiliac joint fusion procedures. The system consists of an instrument set and a wide range of threaded implants. All screws in the 4Web SJTS are cannulated, fenestrated, and made of medical grade Ti6Al4V alloy. The screws come in two distinct sterile implant offerings: a fully threaded screw with compression threads on the proximal head and a partially threaded lag screw with an accompanying washer. The implant offering includes a choice of three different diameters with a variety of lengths to accommodate the patient's anatomy. The SJTS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Indications for Use: The Sacroiliac Joint Truss System is indicated for sacroiliac joint fusion for: - Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. - Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The Sacroiliac Joint Truss System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures. {5} K252834 Page 2 of 2 ## Technological Characteristics Comparison: The subject device and the primary predicate device have similar technological characteristics in terms of intended use, materials, design, function, and performance. The minor differences do not raise any new issues of safety and effectiveness. The subject device when compared to the reference predicate does not introduce any new questions of safety and effectiveness in terms of adoption into the 4Web Medical cleaning and sterilization family. ## Performance Standards: The 4Web Medical Sacroiliac Joint Truss System has been tested per the following test modes: - Static Cantilever Bending per ASTM F3574 - Dynamic Cantilever Bending per ASTM F3574 - Axial Pullout per ASTM F3574 - Static Torsion per ASTM F3574 - Driving Torque per ASTM F3574 - MR Image Artifact per ASTM F2119 - MR induced Heating per ASTM F2182 - MR Induced Torque per ASTM F2213 - MR Induced Displacement Force per ASTM F2051 The results of this non-clinical testing show that the strength of the Sacroiliac Joint Truss System implants is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. ## Conclusion: 4Web Medical concludes that the Sacroiliac Joint Truss System implants are substantially equivalent to the predicate devices and raise no new questions of safety and effectiveness.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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