# K113666: Xia 3 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Aug 28, 2012 after 259 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). 44 ancestors in all.
251 later devices descend from it; 21 cite it directly.
1 of 296 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994121: Small Stature Uss, Synthes (Usa) (2000) Summary page 3.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 3.
- K071668: Orthobiom Spinal System, Paradigm Spine (2008) Summary page 3.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 3.
- K111492: Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments, Materialise NV (2011) Summary page 3.

## Most influential descendants
- K133350: Revere Stabilization System (2014), 93 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
- K130932: Firebird Spinal Fixation System (2013), 81 descendants of its own
- K151488: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (2015), 78 descendants of its own

## Indications for use
The 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 fustion 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 @5.5mm rods from the Stryker Spine Radius™ Spinal System and ©6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System. When used for po'sterior noncervical pedicle screw fixation in pediatric patients, the XIA® 3 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The XIA® 3 Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K113666
Methodology: https://510kreport.com/methodology