Xia 4.5 Spinal System
510(k) K121342
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESU | NumberK121342 | Date22 Jun 2012 | 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- Withdrawn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
- SESU
Overview
AI-generated summary, 19 Sep 2026
The Xia 4.5 Spinal System is a pedicle fixation device designed for spinal stabilization. It features a low-profile tulip head (12.1 mm) and a cortical cancellous thread pattern optimized for fixation in both cortical and cancellous bone, providing secure anchoring in the proximal and distal regions of vertebrae.
This system includes monoaxial and polyaxial bone screws, rods, hooks, and connectors, constructed from titanium and cobalt-chromium-molybdenum alloys. Supplied non-sterile, it is intended for use in orthopedic spinal procedures and has received FDA 510K clearance under K121342. The device is regulated under product code NKB and is intended for surgical stabilization applications as defined by its advisory committee classification.
Other devices from Stryker Corp.
Questions
AI-generated answers, 19 Sep 2026
What types of screws and connectors are included in the Xia 4.5 Spinal System, and how are they designed for spinal stabilization?
The Xia 4.5 Spinal System includes both monoaxial and polyaxial bone screws, along with rods, hooks, and connectors. The screws feature a low-profile tulip head (12.1 mm) and a cortical cancellous thread pattern, which is optimized for secure anchoring in both dense cortical bone and spongy cancellous bone. This design ensures stable fixation in both the proximal and distal regions of vertebrae, supporting spinal stabilization during orthopedic procedures.
Is the Xia 4.5 Spinal System intended for single-use or can it be reused after sterilization?
The Xia 4.5 Spinal System is supplied non-sterile, which implies it is intended for single-use in a surgical setting. Reuse is not recommended or supported by the manufacturer, as sterilization processes may compromise the integrity or performance of the device components.
What materials are used in the construction of the Xia 4.5 Spinal System, and why might this matter?
The Xia 4.5 Spinal System is constructed from titanium and cobalt-chromium-molybdenum alloys. These materials are chosen for their strength, durability, and biocompatibility, which are critical for spinal fixation devices. Titanium is lightweight and resistant to corrosion, while cobalt-chromium-molybdenum alloys provide high strength and wear resistance, ensuring long-term stability and reducing the risk of failure or loosening during spinal stabilization procedures.
How should the Xia 4.5 Spinal System be stored before use, given it is supplied non-sterile?
Since the Xia 4.5 Spinal System is supplied non-sterile, it should be stored in a clean, dry environment protected from moisture, dust, and physical damage. The packaging should remain intact until immediately before use to maintain the device’s condition. Sterilization is not required prior to use, but proper surgical aseptic techniques must be followed during the procedure to ensure sterility at the point of implantation.