# K081898: Expedium Spine System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Sep 10, 2008 after 69 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: 10 generations back to K853033 (1985). 41 ancestors in all.
59 later devices descend from it; 5 cite it directly.
0 of 101 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.
- K063156: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K073126: Expedium Spine System, Depuy Spine, Inc. (2007) Summary page 1.
- K073364: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 1.

## Most influential descendants
- K123352: S4 Spinal System (2012), 51 descendants of its own
- K130291: S4 Spinal System (2013), 44 descendants of its own
- K182377: CarboClear® Pedicle Screw System (2018), 39 descendants of its own
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), 29 descendants of its own
- K190526: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (2019), 28 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 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/K081898
Methodology: https://510kreport.com/methodology