# K052761: Modification to:  Xia 4.5 Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Oct 11, 2005 after 11 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 2 generations back to K950697 (1995). 5 ancestors in all.
735 later devices descend from it; 6 cite it directly.
1 of 741 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050461: Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 1.

## Most influential descendants
- K060361: Xia Spinal System, Xia 4.5 Spinal System (2006), 734 descendants of its own
- K060979: Xia Titanium and 4.5 Spinal Systems (2006), 710 descendants of its own
- K082942: Modfication to: Expedium Spine System (2008), 518 descendants of its own
- K090230: Expedium Spine System (2009), 462 descendants of its own
- K071373: Stryker Spine Xia Iii Spinal System (2007), 430 descendants of its own

## Indications for use
The XIA® 4.5 Spinal System is intended for posterior noncervical pedicle fixation for the following indications: severe spondylolisthesis (i.e. Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion. The XIA® 4.5 Spinal System is also intended for anterolateral and posterior, non-cervical, non-pedicle fixation for the following indications: degenerative disc disease (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 XIA® 4.5 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients only.

Source page: https://510kreport.com/device/K052761
Methodology: https://510kreport.com/methodology