# K113058: Tiger Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Mar 29, 2012 after 167 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: 11 generations back to K990745 (1999). 128 ancestors in all.
81 later devices descend from it; 9 cite it directly.
0 of 210 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110906: Apex Spine System, Spinecraft, LLC (2011) Summary page 2.
- K110321: Tiger Spine System, Corelink, LLC (2011) Summary page 2.

## Most influential descendants
- K131250: Tiger Spine System (2013), 40 descendants of its own
- K151977: icotec Pedicle System (2016), 30 descendants of its own
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), 29 descendants of its own
- K133369: Tiger Spine System (2014), 29 descendants of its own
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own

## Indications for use
The TIGERTM 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 - S1/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/K113058
Methodology: https://510kreport.com/methodology