# K073562: Modification to Viper Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: May 15, 2008 after 148 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: 9 generations back to K853033 (1985). 69 ancestors in all.
213 later devices descend from it; 4 cite it directly.
0 of 283 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050809: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2005) Summary page 1.
- K063670: Modifications to CD Horizon Spinal System, Medtronic Sofamor Danek (2007) Summary page 1.
- K041801: Expedium Mis Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K071860: Modification to: Viper Spine System, Depuy Spine, Inc. (2007) Summary page 1.
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001)
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 3.
- K062174: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 3.

## Most influential descendants
- K111571: Viper Systems (2011), 203 descendants of its own
- K121020: Viper System (2012), 94 descendants of its own
- K153442: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems (2016), 84 descendants of its own
- K121728: Tiger Spine System (2012), 50 descendants of its own
- K161014: NuVasive® Reline® System (2016), 48 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. With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the VIPER Spine System may be used for the aforementioned indications in skeletally mature patients. The EXPEDIUM 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 EXPEDIUMTM 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; pseudarthrosis; and failed previous fusion in skeletally mature patients. With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the EXPEDIUM Spine System may be used for the aforementioned indications in skeletally mature patients.

Source page: https://510kreport.com/device/K073562
Methodology: https://510kreport.com/methodology