# K062698: Trio + Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Oct 11, 2006 after 30 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: 2 generations back to K002858 (2000). 11 ancestors in all.
88 later devices descend from it; 3 cite it directly.
0 of 100 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.
- K052971: Stryker Spine Trio Spinal Fixation System, Stryker Spine (2005) Summary page 1.
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 1.
- K043473: Modification to Xia Spinal System, Stryker Spine (2005) Summary page 1.
- K012870: Xia Stainless Steel System, Howmedica Osteonics Corp. (2001) Summary page 1.
- K050461: Xia 4.5 Spinal System, Stryker Spine (2005) 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

## Recalls of this device
- Apr 25, 2012 · Class II · Z-2235-2012: The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile"
- Jul 1, 2009 · Not classified · Z-1886-2009: The Trio 3.5MM Hex socket has been reported to break under high stresses.

## Indications for use
The TRIO® and TRIO®+ Spinal Systems are pedicle screw systems 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, dislocations, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The TRIO®and TRIO®+ Spinal Systems are 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 TRIO® and TRIO®+ Spinal Systems are sacral/iliac screw fixation systems 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 review of failed fusion attempts. The TRIO® Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors. The TRIO®+ Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, XiMa Pre-bent Rods, and the Multi-Axis Cross Connectors.

Source page: https://510kreport.com/device/K062698
Methodology: https://510kreport.com/methodology