# K041801: Expedium Mis Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Sep 8, 2004 after 68 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: 1 generation back to K032265 (2003). 3 ancestors in all.
533 later devices descend from it; 12 cite it directly.
0 of 537 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K032033: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.
- K032265: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.

## Most influential descendants
- K061520: Viper Spine System (2006), 517 descendants of its own
- K071860: Modification to: Viper Spine System (2007), 423 descendants of its own
- K090648: Viper 2 System (2009), 337 descendants of its own
- K070387: Expedium Spine System (2007), 248 descendants of its own
- K102249: Expedium Spine System (2010), 218 descendants of its own

## Indications for use
The Expedium MIS 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. When used in a percutaneous, posterior approach with MIS Instrumentation, the Expedium MIS System screw components are 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/K041801
Methodology: https://510kreport.com/methodology