# K070368: Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: May 4, 2007 after 85 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K950697 (1995). 18 ancestors in all.
87 later devices descend from it; 2 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043180: Stryker Spine Trio PS, Stryker Spine (2005) Summary page 1.
- K060361: Xia Spinal System, Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 1.
- K032855: Stryker Spine Maps System, Howmedica Osteonics (2003) Summary page 3.
- K052971: Stryker Spine Trio Spinal Fixation System, Stryker Spine (2005) Summary page 3.
- K062698: Trio + Spinal System, Stryker Spine (2006) Summary page 5.

## Cited in the summary but kept off the family tree
- K060369: Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak, Dade Behring, Inc. (2006). Our reading of the summary gave K060369, FDA’s number for Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak… (Dade Behring, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Stryker Spine Opus Spinal System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K100737: Modification to: Trio+Spinal Fixation System (2010), 86 descendants of its own
- K103292: Trio Trauma Spinal System (2011), 85 descendants of its own
- K133188: Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal (2013), 84 descendants of its own
- K142381: Xia 3 Spinal System (2014), 83 descendants of its own
- K152632: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory (2015), 31 descendants of its own

## Indications for use
The Stryker Spine Trio® Plate System is intended for posterior, noncervical (T1 0-Sl) pedical and nonpedical fixation of the spine for the following indications: * Degenerative disc disease (DUD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); * Spondylolisthesis; * Trauma (i.e., fracture or dislocation); * Spinal stenosis; * Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); * Tumor; * Pseudoarthrosis; and * Failed previous fusion. The Stryker Spine Trio® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine Trio® Spinal Fixation System is indicated for: * Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); * Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; * Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and * Failed previous fusion. The Trioe Spinal Fixation System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors. The Stryker Spine Trio®+ Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine Trio®+ Spinal System is indicated for: * Degenerative disc disease (ODD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); * Spondylolisthesis; * Trauma (i.e., fracture or dislocation); * Spinal stenosis; * Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); * Tumor; * Pseudoarthrosis; and * Failed previous fusion. The Trio®4 Spinal System is intended to be used in conjunction with the 055 Diapason Rods, Opus Spinal System Rods, Xia® Pre-bent Rods, and the Multi-Axis Cross Connectors.

Source page: https://510kreport.com/device/K070368
Methodology: https://510kreport.com/methodology