# K060748: Modification to Xia 4.5 Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Apr 13, 2006 after 23 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: 4 generations back to K950697 (1995). 12 ancestors in all.
134 later devices descend from it; 9 cite it directly.
0 of 147 devices in its family (counting itself) have 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.
- K052761: Modification to:  Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 1.
- K060361: Xia Spinal System, Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 1.
- K962628: Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.
- K020709: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.

## Most influential descendants
- K092605: Xia 4.5 Spinal System (2009), 98 descendants of its own
- K121342: Xia 4.5 Spinal System (2012), 88 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
- K111478: Stryker Spine Power Adaptor (Accessory Instrument) (2011), 34 descendants of its own

## Indications for use
The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and 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 Stryker Spine DIAPASONTM Spinal System, Opus TM Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

Source page: https://510kreport.com/device/K060748
Methodology: https://510kreport.com/methodology