# K121728: Tiger Spine System

- Pathway: 510(k) (Special)
- Applicant: Corelink, LLC
- Decided: Oct 5, 2012 after 115 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). 85 ancestors in all.
50 later devices descend from it; 5 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K111571: Viper Systems, Johnson & Johnson (2011) Summary page 1.

## Most influential descendants
- K131250: Tiger Spine System (2013), 40 descendants of its own
- K133369: Tiger Spine System (2014), 29 descendants of its own
- K153453: Inertia Pedicle Screw and Deformity Correxxion System (2016), 17 descendants of its own
- K192121: Black Diamond Pedicle Screw System (2019), 13 descendants of its own
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), 12 descendants of its own

## Indications for use
The TIGERN 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 the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (TI Si/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K121728
Methodology: https://510kreport.com/methodology