Xia 4.5 Spinal System

• • Terminated Z-1525-2009 FDA Unclassified (pre-2012) ·initiated 12 Apr 2007

  Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small.

Full name

Xia Spinal System, Xia 4.5 Spinal System

510(k) Number

K060361 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Tritanium® C Anterior Cervical Cage

  Class II

  FDA 510(k) K262061 Active Cleared 17 Jul 2026

• Modification to Xia 4.5 Spinal System

  Class II

  FDA 510(k) K060748 Active Cleared 13 Apr 2006

• XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi

  Class II

  FDA 510(k) K222684 Active Cleared 8 Jun 2023

• Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal

  Class II

  FDA 510(k) K133188 Active Cleared 17 Dec 2013

• Stryker Spine Vlift Vertebral Body Replacement System

  Class II

  FDA 510(k) K060506 Active Cleared 25 May 2006

• Xia 3 Spinal System

  Class II

  FDA 510(k) K113666 Active Cleared 28 Aug 2012

See all devices from Stryker Spine →

• What types of spinal procedures is the Xia 4.5 Spinal System intended to assist with, and what anatomical regions does it cover?

  The Xia 4.5 Spinal System is designed for non-cervical spinal stabilization, including interior/anteriolateral and posterior approaches. It is intended as an adjunct to spinal fusion procedures in skeletally mature patients, providing secure fixation for these regions. The system’s low-profile tulip head and cortical cancellous thread pattern are engineered to enhance screw placement and surgical visibility.

• Is the Xia 4.5 Spinal System reusable or single-use, and how should it be handled during surgery?

  The Xia 4.5 Spinal System is supplied as a reusable surgical implant. Due to its reusable nature, it must be handled under strict sterile conditions during surgery, adhering to standard surgical instrument protocols to ensure patient safety and prevent contamination.

• What are the key features of the Xia 4.5 Spinal System’s screw design, and how does it benefit the surgeon?

  The system incorporates a cortical cancellous thread pattern, which is engineered to provide enhanced grip and stability in bone. Additionally, the low-profile tulip head (12.1 mm) allows for direct visualization of the surgical site, reducing obstruction and improving precision during placement. These features collectively facilitate secure screw fixation and ease of use.

• Can the Xia 4.5 Spinal System be integrated with other spinal systems or navigation technologies?

  Yes, the Xia 4.5 Spinal System is designed to be compatible with navigation technologies and can be linked to other Stryker spinal systems via rod-to-rod connectors, enabling modularity and flexibility in surgical planning.

• What storage and handling guidelines should be followed for the Xia 4.5 Spinal System?

  The system’s components must be stored and handled according to standard surgical instrument protocols, ensuring they remain clean, dry, and protected from contamination. Since it is reusable, proper sterilization procedures must be followed before reuse to maintain safety and functionality.