# K080928: Xia Spinal System, Stainless Steel Uni-Planar Screws

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Apr 30, 2008 after 28 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: 4 generations back to K950697 (1995). 12 ancestors in all.
182 later devices descend from it; 5 cite it directly.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060361: Xia Spinal System, Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 1.
- K053115: Xia Spinal System, Stryker Spine (2005) Summary page 1.
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 1.

## Most influential descendants
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod (2009), 169 descendants of its own
- K120270: Venus Spinal Fixation System (2012), 111 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
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), 75 descendants of its own

## Indications for use
The Xia® Spinal System is 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 6mm diameter rods from the DIAPASONTM Spinal System and OPUSTM Spinal System are intended to be used with the other components of the Xiae 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/K080928
Methodology: https://510kreport.com/methodology