# K073364: Expedium 4.5MM Spine System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Apr 4, 2008 after 126 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: 3 generations back to K955348 (1996). 6 ancestors in all.
538 later devices descend from it; 11 cite it directly.
1 of 545 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071495: Expedium 4.5MM Spine System, Depuy Spine, A Johnson & Johnson Company (2007) Summary page 1.
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004)
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001)
- K062196: SFX Snap-Fit Cross Connector, Depuy Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- K082942: Modfication to: Expedium Spine System (2008), 518 descendants of its own
- 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

## 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.

Source page: https://510kreport.com/device/K073364
Methodology: https://510kreport.com/methodology