# K142381: Xia 3 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Oct 21, 2014 after 56 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: 16 generations back to K040583 (2004). 170 ancestors in all.
83 later devices descend from it; 12 cite it directly.
0 of 254 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140276: CD Horizon Spinal System, Medtronic Sofamor Danek (2014) Summary page 7.
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 7.
- K133188: Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal, Stryker Spine (2013) Summary page 7.
- K121342: Xia 4.5 Spinal System, Stryker Corp. (2012) Summary page 7.

## Most influential descendants
- K152632: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory (2015), 31 descendants of its own
- K170496: Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory (2017), 15 descendants of its own
- K192121: Black Diamond Pedicle Screw System (2019), 13 descendants of its own
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), 12 descendants of its own
- K200245: EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System (2020), 12 descendants of its own

## Indications for use
The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical 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 (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) • Spondylolisthesis • Trauma (i.e. fracture of dislocation) • Spinal stenosis • Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • Tumor • Pseudarthrosis • Failed previous fusion The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm 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 posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: • Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) • Spondylolisthesis • Trauma (i.e. fracture of dislocation) • Spinal stenosis • Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • Tumor • Pseudarthrosis • Failed previous fusion The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system 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/K142381
Methodology: https://510kreport.com/methodology