# K083393: Xia 3 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Apr 1, 2009 after 135 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: 6 generations back to K950697 (1995). 22 ancestors in all.
292 later devices descend from it; 12 cite it directly.
0 of 315 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 4.
- K062270: Radius Spinal System, Stryker Spine (2006) Summary page 4.
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 4.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 4.

## Most influential descendants
- K120270: Venus Spinal Fixation System (2012), 111 descendants of its own
- K092605: Xia 4.5 Spinal System (2009), 98 descendants of its own
- K100623: Aesculap Implant Systems S4 Spinal System (2010), 92 descendants of its own
- 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

## Recalls of this device
- Dec 30, 2009 · Not classified · Z-0823-2010: The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of Fuchsia. The turquoise color is reserved for the 9.5 mm Xia 3 screws.

## 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 c\1ronic instabilities or deformities: • Degenerative disc disease (ODD) (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 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/K083393
Methodology: https://510kreport.com/methodology