# K063428: Xia Stainless Steel Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Dec 11, 2006 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: 5 generations back to K950697 (1995). 15 ancestors in all.
204 later devices descend from it; 5 cite it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061854: Xia Titanium Spinal System and Xia Stainless Steel Spinal System, Stryker Spine (2006) Summary page 1.
- K012870: Xia Stainless Steel System, Howmedica Osteonics Corp. (2001) Summary page 1.
- K031090: Modification to Xia Stainless Steel System, Howmedica Osteonics Corp. (2003) Summary page 1.
- K951725: Osteonics Spinal System, Osteonics Corp. (1995) 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
- K092631: Mantis Redux Spinal System (2009), 110 descendants of its own
- K102235: Mantis Spinal System & Mantis Redux Spinal System (2010), 109 descendants of its own
- K092605: Xia 4.5 Spinal System (2009), 98 descendants of its own

## Indications for use
The Xia® Stainless Steel 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.

Source page: https://510kreport.com/device/K063428
Methodology: https://510kreport.com/methodology