SI-DESIS X Sacroiliac Joint Fusion System
by Si-Technology, LLC 2 variants
510(k) K251525
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251525 | Date6 Jun 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
- 510(k) Number
- FDA Product Code
- OUR
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SI-DESIS X Sacroiliac Joint Fusion System is a medical device classified as an orthopedic implant designed for sacroiliac joint fusion. It is intended to stabilize and promote fusion of the sacroiliac joint, addressing dysfunction and pain associated with this articulation. The system consists of components specifically engineered to facilitate minimally invasive surgical procedures for joint stabilization. Its primary function is to restore structural integrity and alleviate chronic sacroiliac joint-related discomfort through controlled fixation and fusion.
This system is supplied as a sterile, single-use device intended for use in orthopedic surgical settings. It is approved under FDA 510(k) clearance (K251525) as substantially equivalent to a predicate device, with review by the Orthopedic (OR) Advisory Committee. The device is not MRI-safe and must be handled and stored according to manufacturer instructions to maintain sterility. Sizes and configurations are tailored for specific anatomical applications, ensuring compatibility with surgical techniques for sacroiliac joint intervention.
Other devices from Si-Technology, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the SI-DESIS X Sacroiliac Joint Fusion System used for?
The SI-DESIS X Sacroiliac Joint Fusion System is designed to stabilize and promote fusion of the sacroiliac joint, addressing chronic pain and dysfunction caused by instability in this articulation. It is intended for use in orthopedic surgical procedures where controlled fixation is required to restore structural integrity and alleviate discomfort associated with sacroiliac joint issues.
How is the SI-DESIS X system supplied and what does this mean for its use?
The SI-DESIS X system is supplied as a sterile, single-use device, meaning each package is intended for one surgical procedure only. This ensures patient safety by preventing cross-contamination and maintains the device’s performance standards, as specified by the manufacturer. Sterility must be preserved until use, following the provided handling instructions.
Is the SI-DESIS X system reusable or intended for single-use?
The SI-DESIS X system is explicitly designed for single-use only. This classification is based on its sterile packaging and the manufacturer’s guidelines to prevent reuse, which could compromise sterility, structural integrity, or patient safety. Reuse is not recommended or supported by the manufacturer.
What storage and handling precautions must be followed for the SI-DESIS X system?
The SI-DESIS X system must be stored and handled according to the manufacturer’s instructions to maintain sterility and functionality. This includes keeping the device in its original packaging until use, avoiding exposure to moisture or contamination, and adhering to temperature and environmental guidelines provided by Si-Technology, LLC. Improper storage could compromise the device’s performance or safety.
Are there different sizes or configurations available for the SI-DESIS X system?
Yes, the SI-DESIS X system includes sizes and configurations tailored for specific anatomical applications. These variations ensure compatibility with different patient anatomies and surgical techniques for sacroiliac joint intervention. The manufacturer provides detailed sizing guidance to assist surgeons in selecting the appropriate components for each case.