# K110321: Tiger Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: May 25, 2011 after 111 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 6 generations back to K901587 (1990). 34 ancestors in all.
83 later devices descend from it; 6 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990118: Isobar Spinal System, Scien'Tx USA, Inc. (1999) Summary page 1.
- K013444: Isobar Spinal System, Scien'Tx USA, Inc. (2001) Summary page 1.
- K042673: Zodiac Polyaxial Spinal Fixation System, Alphatec/Nexmed (2004) Summary page 1.
- K033312: Ebi Top Loading Mas Spinal Fixation System, Ebi, L.P. (2004) Summary page 1.
- K061563: Ebi Array Spinal System, Ebi, L.P. (2006) Summary page 1.

## Most influential descendants
- K113058: Tiger Spine System (2012), 81 descendants of its own
- K120696: Tiger Spine System (2012), 41 descendants of its own
- 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

## 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: 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' m Spine System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-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/K110321
Methodology: https://510kreport.com/methodology