# K111571: Viper Systems

- Pathway: 510(k) (Special)
- Applicant: Johnson & Johnson
- Decided: Jul 6, 2011 after 30 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: 12 generations back to K853033 (1985). 84 ancestors in all.
203 later devices descend from it; 9 cite it directly.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073562: Modification to Viper Spine System, Depuy Spine, Inc. (2008) Summary page 2.
- K070387: Expedium Spine System, Depuy Spine, Inc. (2007) Summary page 2.
- K080313: Modification to Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 2.
- K102249: Expedium Spine System, Depuy Spine, A Johnson & Johnson Company (2010) Summary page 2.
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001) Summary page 2.

## Most influential descendants
- 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
- K120696: Tiger Spine System (2012), 41 descendants of its own

## Indications for use
The VIPER Systems are intended to provide immobilization anid staliIization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute anid chronic instabilities or deformities of the thoracie. lumbar anid sacral spine. The VIPER Systems metallic components are intended for noncervical pediele fixation and nonprediele fixation for fusion for the following indications: degenerative disc disease (defined as back Pain of discogenic origin with degeneration ofthe disc confirmed by history and radiographic Studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal steniosis; curvatures (i.e., scoliosis, kyphosis, anid/or lordlosis); tumor, pseuidoarthrosis; anid failed previous fusion in skeletally mature patients. When used in a posterior per-cutaneCous approach with MIS instrumnentation, the VIPER Systems metallic components ave intended for noncervical pedicle Fixation and nonpedicle Fixation for fusion 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, pseudlarthrosis; anid failed previous fusion in skeletally mature patients. The VIPER PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from LI -Si in skeletally mature patients.

Source page: https://510kreport.com/device/K111571
Methodology: https://510kreport.com/methodology