# K081252: Expedium 4.5MM Spine System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: May 30, 2008 after 28 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: 4 generations back to K955348 (1996). 16 ancestors in all.
44 later devices descend from it; 7 cite it directly.
0 of 61 devices in its family (counting itself) have 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.
- K073364: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 1.
- K010576: Monarch Spine System, Depuyacromed (2001) Summary page 1.
- K964007: Acromed Cable/Wire Pedicle Screw, Acromed Corp. (1996) Summary page 1.

## Most influential descendants
- K150417: Astra Spine System (2015), 21 descendants of its own
- K211323: ASTRA Spine System (2021), 12 descendants of its own
- K100757: Tilock Pedicle Screw System (2010), 9 descendants of its own
- K223273: ASTRA Spine System (2022), 8 descendants of its own
- K103671: Genesys Spine Tilock System (2011), 8 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/K081252
Methodology: https://510kreport.com/methodology