# K082942: Modfication to: Expedium Spine System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Oct 31, 2008 after 29 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: 5 generations back to K950697 (1995). 29 ancestors in all.
518 later devices descend from it; 7 cite it directly.
1 of 548 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.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K073364: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 1.
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 1.
- K043488: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 1.
- K080792: K2M Cocr Rod, K2m, Inc. (2008) Summary page 1.

## Most influential descendants
- K090230: Expedium Spine System (2009), 462 descendants of its own
- K090648: Viper 2 System (2009), 337 descendants of its own
- K092473: Expedium Spine System (2009), 263 descendants of its own
- K101070: Expedium Spine System (2010), 260 descendants of its own
- K122226: Revere Stabilization System (2012), 225 descendants of its own

## Indications for use
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIJMTM 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/K082942
Methodology: https://510kreport.com/methodology