# K063156: Modification to Expedium Spine System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Nov 22, 2006 after 36 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). 33 ancestors in all.
424 later devices descend from it; 11 cite it directly.
1 of 458 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051024: Expedium Spine System, Depuy Spine, Inc. (2005)
- K062174: Modification to Expedium Spine System, Depuy Spine, Inc. (2006). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K063741: Expedium Spine System (2007), 398 descendants of its own
- K080313: Modification to Expedium Spine System (2008), 397 descendants of its own
- K063772: Expedium Spine System (2007), 264 descendants of its own
- K092473: Expedium Spine System (2009), 263 descendants of its own
- K101070: Expedium Spine System (2010), 260 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/K063156
Methodology: https://510kreport.com/methodology