# K071860: Modification to: Viper Spine System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Aug 1, 2007 after 27 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: 3 generations back to K032265 (2003). 5 ancestors in all.
423 later devices descend from it; 5 cite it directly.
0 of 429 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.
- K041801: Expedium Mis Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- K090648: Viper 2 System (2009), 337 descendants of its own
- K073562: Modification to Viper Spine System (2008), 213 descendants of its own
- K111571: Viper Systems (2011), 203 descendants of its own
- K102701: Viper Spine System (2010), 184 descendants of its own
- K101993: Viper System, Expedium System (2010), 162 descendants of its own

## Indications for use
The VIPER 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 VIPER 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VIPER 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K071860
Methodology: https://510kreport.com/methodology