# K133369: Tiger Spine System

- Pathway: 510(k) (Special)
- Applicant: Corelink, LLC
- Decided: Jan 14, 2014 after 74 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: 15 generations back to K853033 (1985). 218 ancestors in all.
29 later devices descend from it; 7 cite it directly.
0 of 248 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) Summary page 1.
- K120696: Tiger Spine System, Corelink, LLC (2012) Summary page 1.
- K121728: Tiger Spine System, Corelink, LLC (2012) Summary page 1.
- K131250: Tiger Spine System, Corelink, LLC (2013) Summary page 1.
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K051024: Expedium Spine System, Depuy Spine, Inc. (2005) Summary page 1.
- K062174: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K063156: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K063741: Expedium Spine System, Depuy Spine, Inc. (2007) Summary page 1.
- K080313: Modification to Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 1.
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 1.
- K101993: Viper System, Expedium System, Depuy Spine, Inc. (2010) Summary page 1.
- K062912: Scient'x Spinal System, Scient'X (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K111305: Universal Digital Interface Wireless - Udi 1417W, Meridian Medical Systems, LLC (2012). Our reading of the summary gave K111305, FDA’s number for Universal Digital Interface Wireless - Udi 1417W (Meridian Medical Systems, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “TIGER Spine System”. Kept off the family tree.
- K081898: Expedium Spine System, Depuy Spine, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K240326: Solar™ Lumbar Interbody Fusion System (2024), 4 descendants of its own

## Indications for use
The TIGERS 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/h~ewn): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic stuidies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusaion (pseudartbrosis).

Source page: https://510kreport.com/device/K133369
Methodology: https://510kreport.com/methodology