# K092605: Xia 4.5 Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Dec 3, 2009 after 101 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: 7 generations back to K950697 (1995). 28 ancestors in all.
98 later devices descend from it; 6 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050461: Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 1.
- K060361: Xia Spinal System, Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 1.
- K060748: Modification to Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 1.
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 1.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 1.
- K083393: Xia 3 Spinal System, Stryker Spine (2009) Summary page 1.
- K063428: Xia Stainless Steel Spinal System, Stryker Spine (2006) Summary page 1.
- K020709: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.

## Most influential descendants
- K121342: Xia 4.5 Spinal System (2012), 88 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
- K111478: Stryker Spine Power Adaptor (Accessory Instrument) (2011), 34 descendants of its own
- K120434: Power Adaptor Instrument Accessory (2012), 32 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 in skeletally mature patients as an adjunct to fusion 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.

Source page: https://510kreport.com/device/K092605
Methodology: https://510kreport.com/methodology