FDA 510(k)

SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System

K-Number: K251525 · 2025-06-06

Decision Date2025-06-06

Product CodeOUR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System is a medical device manufactured by Si-Technology, LLC. It received FDA 510(k) clearance on 2025-06-06 under approval number K251525. 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 SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System?

SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by Si-Technology, LLC. The 510(k) number is K251525.

When was SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System approved by the FDA?

SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2025-06-06, under approval number K251525.

What company makes SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System?

SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System is manufactured by Si-Technology, LLC.

What is the FDA product code for SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System?

The FDA product code for SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System is OUR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT06335082 A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF ENROLLING_BY_INVITATION NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 39150225 Lessons on the use of real-world data in medical device research: findings from the National Evaluation System for Health Technology Test-Cases. Journal of comparative effectiveness research (2024) PMID: 37365092 Comparison of the international regulations for medical devices-USA versus Europe. Injury (2023) PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023)

Other Devices by Si-Technology, LLC

K241813SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System

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

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