# K090648: Viper 2 System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Jun 10, 2009 after 91 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: 6 generations back to K950697 (1995). 35 ancestors in all.
337 later devices descend from it; 20 cite it directly.
0 of 373 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082942: Modfication to: Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 1.
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K073364: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 1.
- K071860: Modification to: Viper Spine System, Depuy Spine, Inc. (2007) Summary page 1.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K041801: Expedium Mis Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K933881: Depuy Motech Moss-Miami Spinal System, Depuy, Inc. (1994) Summary page 1.
- K962628: Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 1.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.

## Most influential descendants
- K102701: Viper Spine System (2010), 184 descendants of its own
- K101993: Viper System, Expedium System (2010), 162 descendants of its own
- K131802: Expedium, Viper. Viper 2 Spine System (2013), 139 descendants of its own
- K110906: Apex Spine System (2011), 103 descendants of its own
- K121020: Viper System (2012), 94 descendants of its own

## Indications for use
The 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 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. The PEEK rods of EXPED1UM Spine System and VIPER Systems are contraindicated for degenerative disc disease.

Source page: https://510kreport.com/device/K090648
Methodology: https://510kreport.com/methodology