Trio + Spinal System

• • Terminated Z-2235-2012 FDA Class II ·initiated 25 Apr 2012

  The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.

• • Terminated Z-1886-2009 FDA Unclassified (pre-2012) ·initiated 1 Jul 2009 ·on shared 510(k) K062698

  The Trio 3.5MM Hex socket has been reported to break under high stresses.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K062698 ↗

FDA Product Code

MNI

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 →