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Modification to SI Joint Fusion System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092375

by Si-Bone Inc.

Identifiers

510(k) Number
K092375 FDA 510(k)
FDA Product Code
OUR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Modification to SI Joint Fusion System is a surgical implant designed for sacroiliac joint fusion, classified as an orthopedic device. It provides stabilization to the sacroiliac joint, addressing chronic pain and instability through a minimally invasive approach, ensuring immediate structural support during the fusion process.

This system is supplied as a sterile, single-use device intended for use in orthopedic surgical settings. It is regulated under an FDA 510(k) clearance (K092375) and is intended for use in procedures involving sacroiliac joint fusion, including cases of pelvic fractures. Storage and handling must comply with sterile surgical protocols to maintain device integrity.

Frequently asked questions

What types of surgical procedures is this device intended for, and how does it provide stabilization during surgery?

The Modification to SI Joint Fusion System is designed specifically for sacroiliac joint fusion procedures, including cases involving pelvic fractures. It provides immediate structural support to the sacroiliac joint during surgery, helping to stabilize the area while the fusion process occurs. This is achieved through a minimally invasive approach, ensuring the implant integrates with the joint to restore stability and address chronic pain or instability.

Is this device reusable, or is it intended for single-use only? How should it be stored to maintain sterility?

The Modification to SI Joint Fusion System is a sterile, single-use device, meaning it is intended for one surgical procedure only. To maintain sterility and device integrity, it must be stored and handled according to standard sterile surgical protocols, as outlined in the manufacturer’s instructions. Improper storage could compromise its effectiveness and safety.

How is this device regulated, and what does the FDA clearance indicate about its equivalence to prior devices?

This device holds an FDA 510(k) clearance under the classification K092375, filed under the Orthopedic (OR) advisory committee. The clearance type is marked as Special, and the decision was made that it is Substantially Equivalent (SESE) to a prior device, meaning it has the same intended use and technological characteristics as a legally marketed predicate. This does not imply approval for any specific clinical indication but confirms regulatory compliance for sacroiliac joint fusion procedures.

What should clinicians consider when selecting this device for a patient, given its intended use?

Clinicians should consider this device for patients requiring sacroiliac joint fusion due to chronic pain, instability, or pelvic fractures. Since it is designed for a minimally invasive approach, it may be particularly relevant for cases where traditional open surgery is less desirable. The system’s immediate stabilization feature ensures structural support during the fusion process, which could be beneficial for patients needing rapid postoperative stability. Always follow the manufacturer’s instructions for proper sizing, placement, and postoperative care.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SI Joint Surgery | The iFuse Implant Systems | SI-BONE, iFuse 3D™ - SI-BONE, SI-BONE | iFuse: The Triangle-Shaped Implant Designed Specifically for ..., For Medical Professionals: The iFuse Implant System | SI-BONE

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Si-Bone Inc.
FDA Applicant
SI-BONE, Inc.

Sources (1)

  • FDA 510(k) K092375 24 fields · synced Sep 19, 2026