# K103292: Trio Trauma Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Mar 4, 2011 after 116 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: 8 generations back to K950697 (1995). 54 ancestors in all.
85 later devices descend from it; 1 cites it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010658: Modified Uss Fracture System, Synthes (Usa) (2001) Summary page 1.
- K102235: Mantis Spinal System & Mantis Redux Spinal System, Stryker Spine (2010) Summary page 1.
- K100737: Modification to: Trio+Spinal Fixation System, Stryker Spine (2010) Summary page 1.
- K052971: Stryker Spine Trio Spinal Fixation System, Stryker Spine (2005) Summary page 1.
- K050461: Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 1.
- K052761: Modification to:  Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 1.

## Most influential descendants
- 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
- K192121: Black Diamond Pedicle Screw System (2019), 13 descendants of its own

## Indications for use
The Stryker Spine TRIO TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle 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 (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; Pseudloarthrosis; and Failed previous fusion.

Source page: https://510kreport.com/device/K103292
Methodology: https://510kreport.com/methodology