# K052971: Stryker Spine Trio Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Nov 16, 2005 after 23 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951725 (1995). 4 ancestors in all.
112 later devices descend from it; 6 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032855: Stryker Spine Maps System, Howmedica Osteonics (2003) Summary page 1.
- K951725: Osteonics Spinal System, Osteonics Corp. (1995) Summary page 1.
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 3.
- K012870: Xia Stainless Steel System, Howmedica Osteonics Corp. (2001) Summary page 1.

## Most influential descendants
- K062698: Trio + Spinal System (2006), 88 descendants of its own
- 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

## Recalls of this device
- Jul 1, 2009 · Not classified · Z-1886-2009: The Trio 3.5MM Hex socket has been reported to break under high stresses.
- Sep 5, 2006 · Not classified · Z-0986-2009: Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.

## Indications for use
The Stryker Spine TRIO® Spinal Fixation System is a pedicle screw 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Stryker Spine TRIO® Spinal Fixation System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the development of a solid fusion mass. The Stryker Spine TRIO® Spinal Fixation System is also a sacral/iliac 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 (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts. The Stryker Spine TRIO® Spinal Fixation System is also intended to be used in conjunction with the OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Connectors.

Source page: https://510kreport.com/device/K052971
Methodology: https://510kreport.com/methodology