# K131250: Tiger Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Sep 10, 2013 after 131 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: 14 generations back to K853033 (1985). 203 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 244 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110321: Tiger Spine System, Corelink, LLC (2011)
- K120696: Tiger Spine System, Corelink, LLC (2012) Summary page 2.
- K113058: Tiger Spine System, Corelink, LLC (2012) Summary page 1.
- K121728: Tiger Spine System, Corelink, LLC (2012) Summary page 1.
- K101070: Expedium Spine System, Medos International SARL (2010) Summary page 2.
- K024348: Monarch Spine System, Depuyacromed (2003) Summary page 1.
- K010576: Monarch Spine System, Depuyacromed (2001) Summary page 2.
- K014137: Modification to Ebi Omega 21 System, Ebi, L.P. (2002) Summary page 1.
- K001357: Modification to Omega 21 System, Ebi, L.P. (2000)
- K992333: Ebi Omega 21 System, Electro-Biology, Inc. (1999) Summary page 1.
- K991721: Ebi Omega 21 System, Ebi Electro Biology (1999) Summary page 1.
- K990303: Ebi Omega 21 System, Electro-Biology, Inc. (1999) Summary page 1.
- K973683: Omega 21 System, Ebi Electro Biology (1997) Summary page 1.
- K021170: TSRH Spinal System, Medtronic Sofamor Danek USA, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own

## Indications for use
The TIGER® 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 spine (T1-S1/ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history of and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K131250
Methodology: https://510kreport.com/methodology