# K120696: Tiger Spine System

- Pathway: 510(k) (Special)
- Applicant: Corelink, LLC
- Decided: Apr 2, 2012 after 26 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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). 123 ancestors in all.
41 later devices descend from it; 3 cite it directly.
0 of 165 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.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K111571: Viper Systems, Johnson & Johnson (2011) Summary page 1.
- K000236: Synergy VLS Cap Nut Models 2206, 6102, Interpore Cross Intl. (2000) Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 1.
- K992739: Click'x, Synthes Spine (2000) Summary page 1.
- K052123: Synthes Pangea System, Synthes (Usa) (2005) 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 TIGET 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, arnd sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a pedicle screw system, the TIGER h Spine System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K120696
Methodology: https://510kreport.com/methodology