Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod
510(k) K091291
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK091291 | Date24 Jun 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NKB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Xia 3 Spinal System is a spinal fixation device classified as a Spinal Fixation Device (Nomenclature Code: NKB). It combines pedicle screws, rods, and connecting hardware to stabilize the spine, addressing degenerative conditions, trauma, tumors, and deformities through surgical intervention. The system includes titanium and Vitallium rods of varying diameters (5.5 mm and 6.0 mm) designed for intraoperative flexibility and reduction capabilities. Uniplanner screws facilitate precise alignment and load-sharing across spinal segments.
This system is intended for surgical use in spinal stabilization procedures and is supplied as a reusable surgical instrument set paired with single-use implants. The rods and screws are sterile, packaged for one-time surgical use, and must be handled according to sterile technique. The system is MRI-unsafe due to metallic components and requires proper disposal or reprocessing of reusable tools per facility protocols. Authorized for use in the United States under FDA 510K clearance (K091291), it adheres to orthopedic surgical standards for spinal fixation.
Other devices from Stryker Spine
Questions
AI-generated answers, 19 Sep 2026
What types of spinal conditions is the Xia 3 Spinal System designed to address in surgical procedures?
The Xia 3 Spinal System is intended for surgical stabilization of the spine in cases involving degenerative conditions, trauma, tumors, and deformities. Its design combines pedicle screws, rods, and connecting hardware to provide structural support and alignment during these procedures.
Are the rods and screws in the Xia 3 Spinal System reusable or single-use, and how should they be handled?
The rods and screws in the Xia 3 Spinal System are single-use implants and come sterile-packaged for one surgical procedure. They must be handled using strict sterile techniques to maintain integrity and prevent contamination, as they are not intended for reuse.
What rod diameters are available in the Xia 3 Spinal System, and how do they contribute to its functionality?
The system includes titanium and Vitallium rods in two diameters: 5.5 mm and 6.0 mm. These varying diameters allow intraoperative flexibility and enable precise load-sharing and reduction across spinal segments, aiding in achieving optimal alignment during fixation.
Is the Xia 3 Spinal System safe for use in MRI environments, and what disposal or reprocessing guidelines apply?
No, the Xia 3 Spinal System is MRI-unsafe due to its metallic components. Reusable surgical instruments from the system must be disposed of or reprocessed according to facility protocols to ensure safety and compliance with surgical standards.
How is the Xia 3 Spinal System’s Uniplanner screw feature beneficial in spinal stabilization procedures?
The Uniplanner screws in the Xia 3 Spinal System are designed to enable precise alignment and load-sharing across spinal segments. This feature helps distribute forces evenly, improving stability and reducing stress on individual screws during fixation, which is particularly useful in complex spinal reconstructions.