# K060361: Xia Spinal System, Xia 4.5 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Mar 6, 2006 after 21 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K950697 (1995). 11 ancestors in all.
734 later devices descend from it; 19 cite it directly.
1 of 746 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053115: Xia Spinal System, Stryker Spine (2005) Summary page 1.
- K052761: Modification to:  Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 1.
- K032033: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.

## Most influential descendants
- K060979: Xia Titanium and 4.5 Spinal Systems (2006), 710 descendants of its own
- K082942: Modfication to: Expedium Spine System (2008), 518 descendants of its own
- K090230: Expedium Spine System (2009), 462 descendants of its own
- K071373: Stryker Spine Xia Iii Spinal System (2007), 430 descendants of its own
- K090648: Viper 2 System (2009), 337 descendants of its own

## Recalls of this device
- Apr 12, 2007 · Not classified · Z-1525-2009: Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small.

## Indications for use
The Xia® Spinal System and Xia® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (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 6 mm diameter rods from the DIAPASON T M Spinal System and OPUSTM Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

Source page: https://510kreport.com/device/K060361
Methodology: https://510kreport.com/methodology