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FDA 510(k)

Sacroiliac Joint Truss System (SJTS)

K-Number: K252834 · 2026-01-28

Applicant4Web Medical
Decision Date2026-01-28
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sacroiliac Joint Truss System (SJTS) is a medical device manufactured by 4Web Medical. It received FDA 510(k) clearance on 2026-01-28 under approval number K252834. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sacroiliac Joint Truss System (SJTS)?

Sacroiliac Joint Truss System (SJTS) is a medical device that received FDA 510(k) clearance on 2026-01-28. It is manufactured by 4Web Medical. The 510(k) number is K252834.

When was Sacroiliac Joint Truss System (SJTS) approved by the FDA?

Sacroiliac Joint Truss System (SJTS) received FDA 510(k) clearance on 2026-01-28, under approval number K252834.

What company makes Sacroiliac Joint Truss System (SJTS)?

Sacroiliac Joint Truss System (SJTS) is manufactured by 4Web Medical.

What is the FDA product code for Sacroiliac Joint Truss System (SJTS)?

The FDA product code for Sacroiliac Joint Truss System (SJTS) is OUR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

Other Devices by 4Web Medical

K251117Cervical Spine Truss System (CSTS)

Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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