# K103133: Veper System, Expedium System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Jan 18, 2011 after 85 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: 12 generations back to K853033 (1985). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 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 2.
- K051024: Expedium Spine System, Depuy Spine, Inc. (2005) Summary page 2.
- K062174: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 2.
- K063156: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 2.
- K063741: Expedium Spine System, Depuy Spine, Inc. (2007) Summary page 2.
- K080313: Modification to Expedium Spine System, Depuy Spine, Inc. (2008)
- K081898: Expedium Spine System, Depuy Spine, Inc. (2008)
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 2.

## Indications for use
The EXPEDIUMv and VIPER Systems are 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 and VIPER Systems are intended for noncervicall 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. When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are 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/K103133
Methodology: https://510kreport.com/methodology