# K043180: Stryker Spine Trio PS

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Mar 2, 2005 after 105 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 1 generation back to K951725 (1995). 2 ancestors in all.
88 later devices descend from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 1.
- K951725: Osteonics Spinal System, Osteonics Corp. (1995) Summary page 1.

## Most influential descendants
- K070368: Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System (2007), 87 descendants of its own
- 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

## Indications for use
The Stryker Spine TRIO® PS is a posterior, noncervical (T10-S1). pediole system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients: As an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the spine: severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesls with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) tumor, pseudoarthrosis, and previous failed fusion. The Stryker Spine TRIO® PS is also a sacral screw fixation system indicated for 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, deformities or curvatures (I.e,, scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and previous failed fusion.

Source page: https://510kreport.com/device/K043180
Methodology: https://510kreport.com/methodology