# K121020: Viper System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: May 3, 2012 after 29 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). 107 ancestors in all.
94 later devices descend from it; 4 cite it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102701: Viper Spine System, Depuy Spine, Inc. (2010) Summary page 2.
- K111571: Viper Systems, Johnson & Johnson (2011) Summary page 2.

## Most influential descendants
- 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
- K161014: NuVasive® Reline® System (2016), 48 descendants of its own
- K170126: NuVasive® Reline® 4.5-5.0 System (2017), 39 descendants of its own
- K221244: CD Horizon™ Spinal System (2022), 20 descendants of its own
- K223494: CD Horizon Spinal System (2023), 17 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 of deformities of the thoracic, lumbar, and sacral spine. The VIPER System is intended for noncervical pedlicle 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 lordlosis); tumor, pseudloarthrosis; and failed previous fusion in skeletally mature patients. When used in a percutaneous, posterior approach with MIS instrumentation, VIPER Systems are intended for noncervical pedicle fixation and nonpedlicle 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 lordlosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K121020
Methodology: https://510kreport.com/methodology