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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 the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical. It received FDA 510(k) clearance on 2026-01-28 under 510(k) 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. The listed applicant is 4Web Medical. The 510(k) number is K252834.

When did Sacroiliac Joint Truss System (SJTS) receive FDA 510(k) clearance?

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

Who is the listed applicant for Sacroiliac Joint Truss System (SJTS)?

The FDA 510(k) record lists 4Web Medical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing 4Web Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)K251117Cervical Spine Truss System (CSTS)K240388Osteotomy Truss System (OTS)K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)K230088Ankle Truss System (ATS)K231739Cervical Spine Truss System (CSTS)

View all 13 devices →

Related Devices (Code: OUR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys SpineK253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.

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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