# K041205: Expedium Anterior Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Aug 17, 2004 after 102 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K953915 (1996). 4 ancestors in all.
140 later devices descend from it; 1 cites it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012916: Frontier Anterior Scoliosis System, Depuy Acromed, Inc. (2001) Summary page 1.

## Most influential descendants
- K131802: Expedium, Viper. Viper 2 Spine System (2013), 139 descendants of its own
- K181677: Kodiak Spinal Fixation System (2018), 70 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K203056: Invictus™ Spinal Fixation System (2020), 61 descendants of its own
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own

## Indications for use
The Expedium Tm Anterior Spine System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The Expedium Anterior Spine System may be used in either thoracoscopic procedures or open procedures. The Expedium Anterior Spine System is indicated for: 1. degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies 2. spondylolisthesis 3. trauma (i.e., fracture or dislocation) 4. spinal stenosis 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) 6. tumor 7. pseudarthrosis 8. previous failed fusion

Source page: https://510kreport.com/device/K041205
Methodology: https://510kreport.com/methodology