SIMMETRY Sacroiliac Joint Fusion System
by Zyga Technology, Inc. 510(k)
Active
510(k) K130092
Overview
The SIMMETRY Sacroiliac Joint Fusion System is a medical device designed for sacroiliac joint fusion, a procedure to stabilize the sacroiliac joint and alleviate chronic pain. Classified under orthopedic implants, it is intended to provide structural support and promote bony fusion between the sacrum and ilium, addressing dysfunction in this joint. The system includes instrumentation tailored for minimally invasive surgical techniques to enhance precision and reduce tissue trauma during placement.
This system is supplied sterile and intended for single-use, as indicated by its FDA 510(k) clearance under the Special review pathway for orthopedic devices. It is used in an operating room setting by surgeons specializing in spinal or orthopedic procedures. The device’s proprietary components, including the decorticator, facilitate preparation of the joint surface to optimize fusion outcomes. Storage and handling must comply with sterile medical device protocols to ensure integrity before use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130092 | Date27 Feb 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from Zyga Technology, Inc.
Questions
What is the SIMMETRY Sacroiliac Joint Fusion System used for?
This system is designed to stabilize the sacroiliac (SI) joint through fusion surgery, providing structural support and promoting bony integration between the sacrum and ilium. It targets chronic pain caused by SI joint dysfunction, offering a minimally invasive approach to reduce tissue trauma during placement. The proprietary decorticator included in the system helps prepare the joint surface for optimal fusion outcomes.
How is the SIMMETRY Sacroiliac Joint Fusion System supplied and prepared for use?
The system is supplied sterile and intended for single-use only, as confirmed by its FDA 510(k) clearance under the Special review pathway. Before use, it must be handled according to sterile medical device protocols to maintain its integrity. The sterile packaging ensures readiness for immediate use in the operating room by surgeons specializing in spinal or orthopedic procedures.
Is the SIMMETRY Sacroiliac Joint Fusion System reusable or single-use?
The SIMMETRY Sacroiliac Joint Fusion System is explicitly designed for single-use, as indicated by its FDA clearance and manufacturer guidelines. This ensures patient safety and sterility, as reuse could compromise the device’s integrity and increase infection risks. The sterile packaging reinforces this restriction.
What surgical approach does the SIMMETRY Sacroiliac Joint Fusion System support?
The system is tailored for minimally invasive surgical techniques, allowing surgeons to place the fusion components with greater precision while minimizing tissue trauma. This approach reduces recovery time and complications compared to traditional open surgery, making it suitable for patients seeking less invasive SI joint stabilization.
How should the SIMMETRY Sacroiliac Joint Fusion System be stored before use?
Storage must adhere to sterile medical device protocols to preserve the system’s integrity. The sterile packaging should remain unopened until immediately before use in the operating room. Proper storage conditions—such as avoiding extreme temperatures or contamination—are critical to maintaining sterility and functionality until deployment by the surgeon.