# K071373: Stryker Spine Xia Iii Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Aug 27, 2007 after 103 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: 5 generations back to K950697 (1995). 21 ancestors in all.
430 later devices descend from it; 24 cite it directly.
1 of 452 devices in its family (counting itself) has 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.
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 1.
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 1.
- K062270: Radius Spinal System, Stryker Spine (2006) Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.

## Most influential descendants
- K083393: Xia 3 Spinal System (2009), 292 descendants of its own
- K113666: Xia 3 Spinal System (2012), 251 descendants of its own
- 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
- K092605: Xia 4.5 Spinal System (2009), 98 descendants of its own

## Recalls of this device
- Jan 12, 2012 · Not classified · Z-1706-2012: Stryker received four reports regarding a handle which separates at the point where it is welded to the shaft on the Xia 3 Anti-Torque Key during surgery.

## Indications for use
The Stryker Spine XIA® III 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® III 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 05.5mm rods from the Stryker Spine RadiusM Spinal System and 06.0 mm Vitallium rods from XIA® Spinal System are intended to be used with the other components of XIA® III Spinal System.

Source page: https://510kreport.com/device/K071373
Methodology: https://510kreport.com/methodology