# K070387: Expedium Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Sep 18, 2007 after 221 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: 9 generations back to K853033 (1985). 47 ancestors in all.
248 later devices descend from it; 4 cite it directly.
0 of 296 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.
- K062174: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K041801: Expedium Mis Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001) Summary page 1.
- K052385: Tangors Polyaxial System, Ulrich GmbH & Co. KG (2005)
- K032059: Modification to Macs Modular Anterior Construct System, Aesculap, Inc. (2003) Summary page 1.

## Most influential descendants
- K102249: Expedium Spine System (2010), 218 descendants of its own
- K111571: Viper Systems (2011), 203 descendants of its own
- K121020: Viper System (2012), 94 descendants of its own
- K153442: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems (2016), 84 descendants of its own
- K121728: Tiger Spine System (2012), 50 descendants of its own

## Indications for use
The EXPEDIUMTM 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; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K070387
Methodology: https://510kreport.com/methodology