# K050675: Expedium Spine System Spinous Process Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Apr 11, 2005 after 26 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 1 generation back to K033901 (2004). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 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.
- (no number) Wilson Spinal Plate: named in the summary without a submission number

## Most influential descendants
- K102020: Vega Span Spinous Process Plate System (2010), 8 descendants of its own
- K213266: Inspan ScrewLES Fusion System (2021), 3 descendants of its own
- K121316: Lanx Spinal Fization System (2012), 3 descendants of its own
- K131156: Lanx Spinal Fixation System (2013), 1 descendant of its own
- K232605: Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System (2023), 0 descendants of its own

## Indications for use
The EXPEDIUM Spine System is intended for non-cervical, non-pedicle 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. The Expedium Spinous Process Fusion Plate is not intended for stand-alone use. When used with DePuy Spine VBR Spinal System components the Expedium Spinous Process Fusion Plate is intended for the following conditions: * 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) * tumor

Source page: https://510kreport.com/device/K050675
Methodology: https://510kreport.com/methodology