Stryker Spine Trio PS

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K043180 ↗

FDA Product Code

MNH

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 Stryker Spine Trio PS system intended to support as an adjunct?

  The Stryker Spine Trio PS is designed specifically as an adjunct to spinal fusion procedures, providing immobilization and stabilization for non-cervical spinal segments (thoracic T10 through sacral S1) in skeletally mature patients. It is not intended for cervical spine applications or standalone stabilization.

• Is the Stryker Spine Trio PS system reusable, or is it meant for single-use only?

  The system is explicitly intended for single-use, as stated in the manufacturer’s specifications. This aligns with its sterile packaging and lack of any reusable design indicators, ensuring compliance with infection control protocols for orthopedic implants.

• What components are included in the Stryker Spine Trio PS system, and how is it supplied?

  The system includes pedicle screws, rods, and connecting hardware, all supplied sterile in a single-use configuration. The sterile packaging ensures readiness for immediate surgical use without additional processing, which is critical for maintaining procedural efficiency and sterility.

• Does the Stryker Spine Trio PS system have any MRI safety considerations, or is it contraindicated for MRI use?

  The provided data does not specify an MRI safety classification for the Stryker Spine Trio PS system, meaning its compatibility with MRI environments is not addressed. Clinicians should consult the full labeling or manufacturer guidance before considering MRI use with this device.

• How was the FDA clearance for the Stryker Spine Trio PS system determined, and what does that mean for its regulatory status?

  The system received FDA clearance through the Traditional 510(k) pathway (K043180) with a decision code of SESE, meaning it was determined to be *substantially equivalent* to a legally marketed predicate device. This clearance route confirms its compliance with FDA standards for orthopedic spinal fixation systems, but does not imply approval for any specific clinical indication beyond its labeled use.