# K100737: Modification to: Trio+Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Apr 12, 2010 after 28 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: 5 generations back to K950697 (1995). 21 ancestors in all.
86 later devices descend from it; 2 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052971: Stryker Spine Trio Spinal Fixation System, Stryker Spine (2005) Summary page 1.
- K062698: Trio + Spinal System, Stryker Spine (2006) Summary page 1.
- K070368: Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System, Stryker Corp. (2007) Summary page 1.
- K020699: TSRH Spinal System, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.
- K021170: TSRH Spinal System, Medtronic Sofamor Danek USA, Inc. (2002)

## Most influential descendants
- 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
- K170496: Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory (2017), 15 descendants of its own

## Indications for use
The Stryker Spine TRIO+ Spinal Fixation System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: *Degenerative disc disease (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+ Spinal Fixation System is intended to be used in conjunction with the OSS/DIAPASON or Opus Rods, Xia pre-bent rods and the Multi-Axia Cross Connector.

Source page: https://510kreport.com/device/K100737
Methodology: https://510kreport.com/methodology