SI-DESIS X Sacroiliac Joint Fusion System
by Si-Technology, LLC 2 variants
510(k) K241813
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241813 | Date13 Aug 2024 | 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- Withdrawn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 device classified as an orthopedic implant designed for sacroiliac joint fusion. It is intended to stabilize and promote fusion of a dysfunctional sacroiliac joint, addressing chronic pain and instability in skeletally mature patients. The system employs minimally invasive techniques to facilitate proper fixation and immobilization of the joint, aiding in long-term relief and functional restoration. Its design aligns with orthopedic fusion solutions, targeting the sacroiliac region to restore structural integrity and alleviate associated discomfort.
This system is supplied as a sterile, single-use orthopedic implant and is regulated under FDA 510(k) clearance (K241813) as substantially equivalent to existing devices in the orthopedic category. It is intended for use in surgical settings by trained orthopedic surgeons during procedures involving lumbar or thoracolumbar fixation. The device is not MRI-safe and must be handled and stored according to manufacturer guidelines to maintain sterility and functionality. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the specifications.
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 a dysfunctional sacroiliac joint in skeletally mature patients. It addresses chronic pain and instability by providing structural support to the joint, enabling long-term relief and functional restoration through minimally invasive surgical techniques.
Is the SI-DESIS X system single-use or reusable?
The SI-DESIS X Sacroiliac Joint Fusion System is supplied as a sterile, single-use orthopedic implant. This ensures patient safety and sterility, as reuse could compromise integrity and introduce infection risks. Always follow manufacturer guidelines for proper handling and disposal.
Can this device be used with MRI scans after implantation?
No, the SI-DESIS X Sacroiliac Joint Fusion System is not MRI-safe. Patients implanted with this device should avoid MRI procedures, as the metallic components could cause artifacts or pose safety risks during imaging.
What are the key considerations for storage and handling?
To maintain sterility and functionality, the SI-DESIS X system must be stored and handled according to the manufacturer’s guidelines. This includes keeping it in its original packaging until use and ensuring it is not exposed to contamination or physical damage. Proper storage conditions prevent degradation and ensure the device performs as intended during surgery.
Who should perform the implantation procedure?
The SI-DESIS X Sacroiliac Joint Fusion System is intended for use in surgical settings by trained orthopedic surgeons. The procedure involves lumbar or thoracolumbar fixation, so only qualified professionals with experience in spinal and orthopedic surgeries should perform the implantation to ensure proper technique and patient outcomes.