# K121342: Xia 4.5 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Jun 22, 2012 after 49 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: 10 generations back to K040583 (2004). 112 ancestors in all.
88 later devices descend from it; 5 cite it directly.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 3.
- K102807: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2010) Summary page 3.
- K994121: Small Stature Uss, Synthes (Usa) (2000) Summary page 3.
- K103287: Synthes 6.0 Cocr and CPT TI-3 Rods, Synthes Spine (2011) Summary page 3.
- K092605: Xia 4.5 Spinal System, Stryker Spine (2009) Summary page 2.
- K060361: Xia Spinal System, Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 2.

## 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 XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation 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 Stryker Spine DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, the XIA 4.5 Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pedicle screw fixation in pediatric patients. The XIA 4.5 Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K121342
Methodology: https://510kreport.com/methodology