# K050461: Xia 4.5 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Jul 27, 2005 after 154 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 1 generation back to K950697 (1995). 4 ancestors in all.
742 later devices descend from it; 12 cite it directly.
1 of 747 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002858: Xia Spine System, Howmedica Osteonics Corp. (2000) Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.
- K962628: Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 1.
- K020709: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.

## Most influential descendants
- K052761: Modification to:  Xia 4.5 Spinal System (2005), 735 descendants of its own
- 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

## 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.

Source page: https://510kreport.com/device/K050461
Methodology: https://510kreport.com/methodology