iFuse INTRA Ti Implant System
FDA 510(k)Class II (US FDA 510(k))
by Si-Bone Inc.
Identifiers
- 510(k) Number
- K253488 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 iFuse INTRA Ti Implant System is a sacroiliac joint implant designed for stabilization and fusion. It consists of cannulated triangular titanium implants with a porous surface, intended to prevent rotational motion and promote joint stabilization. This device is classified as an orthopedic implant under FDA regulatory oversight, specifically within the Orthopedic (OR) advisory committee category.
The system is supplied with an instrument set that includes guide pins for precise implant placement. It is intended for use in a surgical setting and is classified as a reusable instrument system paired with single-use implants. The device is approved under a Traditional 510(k) pathway, with clearance granted as substantially equivalent to a predicate device. Storage and handling follow standard orthopedic implant protocols, ensuring sterility and proper surgical technique.
Frequently asked questions
What is the iFuse INTRA Ti Implant System used for?
The iFuse INTRA Ti Implant System is designed to stabilize and promote fusion of the sacroiliac joint. It achieves this through cannulated triangular titanium implants with a porous surface, which help prevent rotational motion and integrate with the bone over time. This is particularly useful for patients experiencing sacroiliac joint dysfunction or instability.
How is the iFuse INTRA Ti Implant System supplied?
The system is supplied with a reusable instrument set that includes guide pins for precise surgical placement of the implants. The implants themselves are single-use, while the instruments are intended for reuse across multiple procedures, following proper sterilization and handling protocols.
Are the implants sterile and how should they be stored?
The iFuse INTRA Ti Implant System is designed to maintain sterility through standard orthopedic implant protocols. Implants should be stored in a clean, dry environment, protected from contamination, and handled using aseptic techniques to ensure their integrity before and during surgery.
Is this device reusable or single-use?
The implants in the iFuse INTRA Ti Implant System are single-use, meaning they are intended for one surgical procedure only. In contrast, the accompanying instrument set is reusable, provided it undergoes proper cleaning, sterilization, and maintenance between uses.
What regulatory pathway was used for clearance of this device?
The iFuse INTRA Ti Implant System received clearance through the FDA’s Traditional 510(k) pathway, where it was determined to be substantially equivalent to a predicate device. This pathway is used for devices that are similar to existing approved products, ensuring they meet established safety and effectiveness standards.
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: iFuse INTRA Ti™ | SI-BONE, iFuse INTRA Ti™ | SI-BONE, For Medical Professionals: The iFuse Implant System | SI-BONE
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253488 | Class II | Active |
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Manufacturer
- Manufacturer
- Si-Bone Inc.
- FDA Applicant
- SI-BONE, Inc.
Sources (1)
- FDA 510(k) K253488 24 fields · synced Oct 1, 2026