# K090799: Modification to Expedium Spine System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Apr 22, 2009 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: 9 generations back to K853033 (1985). 39 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073126: Expedium Spine System, Depuy Spine, Inc. (2007) Summary page 1.
- K082195: Modifications to Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 1.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K062174: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 1.
- K062196: SFX Snap-Fit Cross Connector, Depuy Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- K133575: Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation System (2014), 3 descendants of its own
- K160124: LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System (2016), 2 descendants of its own
- K200267: LOSPA® IS™ Spinal Fixation System (2020), 1 descendant of its own
- K240180: Orthopeasia Spinal Fixation System (2024), 0 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 EXPEDIUM 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/K090799
Methodology: https://510kreport.com/methodology