# K041119: Expedium Spine System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Jul 19, 2004 after 81 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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 K033901 (2004). 1 ancestor in all.
640 later devices descend from it; 29 cite it directly.
1 of 642 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 1.

## Most influential descendants
- K073364: Expedium 4.5MM Spine System (2008), 538 descendants of its own
- K082942: Modfication to: Expedium Spine System (2008), 518 descendants of its own
- K051024: Expedium Spine System (2005), 493 descendants of its own
- K062174: Modification to Expedium Spine System (2006), 490 descendants of its own
- K090230: Expedium Spine System (2009), 462 descendants of its own

## Indications for use
The Expedium TM Spine System is intended for noncervical pedicle fixation and nonpedicle 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 in skeletally mature patients.

Source page: https://510kreport.com/device/K041119
Methodology: https://510kreport.com/methodology