# K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Jun 24, 2009 after 54 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: 6 generations back to K950697 (1995). 39 ancestors in all.
169 later devices descend from it; 9 cite it directly.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 1.
- K080928: Xia Spinal System, Stainless Steel Uni-Planar Screws, Stryker Spine (2008) Summary page 1.
- K063428: Xia Stainless Steel Spinal System, Stryker Spine (2006) Summary page 1.
- K062270: Radius Spinal System, Stryker Spine (2006) Summary page 1.
- K082608: Radius Spinal System, Vitallium Rod #486613601, Stryker Spine (2008) Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K081823: Masterscreen Paed - Baby Body, Viasys Healthcare GmbH (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K131615: Polaris Spinal System (2013), 70 descendants of its own

## Indications for use
The Stryker Spine XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 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 05.5 mm titanium and Vitallium® rods from the Stryker Spine Radius® Spinal System and 06.0 mm Vitallium® rods from XIA Spinal System are intended to be used with the other components of XIA® 3 Spinal System.

Source page: https://510kreport.com/device/K091291
Methodology: https://510kreport.com/methodology