# K110216: Expedium System, Viper System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Apr 1, 2011 after 66 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: 13 generations back to K853033 (1985). 73 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 78 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) Summary page 2.
- K081898: Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 2.
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 2.
- K101993: Viper System, Expedium System, Depuy Spine, Inc. (2010) Summary page 2.

## Most influential descendants
- K121130: Polaris Spinal System-Ballista Spinal Rods (2012), 1 descendant of its own
- K191212: CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System (2019), 0 descendants of its own
- K123451: Polaris Spinal System - Ballista II Rods (2012), 0 descendants of its own
- K120928: Synthes Matrix System (2012), 0 descendants of its own

## Indications for use
The EXPEDIUM 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 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. 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K110216
Methodology: https://510kreport.com/methodology