# K132504: Tiger Occipital-Cervical-Thoracic Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Nov 25, 2013 after 105 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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 K003155 (2001). 106 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121725: Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System, Pioneer Surgical Technology, Inc. (2012) Summary page 2.
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011)
- K091689: Synapse System 4.0MM, OC Fusion System 4.0MM, Synthes (Usa) (2009) Summary page 2.

## Most influential descendants
- K200571: PERLA® Posterior Occipito-Cervico-Thoracic Fixation System (2020), 0 descendants of its own
- K200863: Tiger® Occipital-Cervical-Thoracic Spinal Fixation System (2020), 0 descendants of its own

## Indications for use
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is intended to promote fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3). The system is intended to be used in skeletally mature patients as an adjunct to fusion using autograft and allograft for the following conditions: degenerative disc disease (DDD): defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies: spondylolisthesis; spinal stenosis; fracture/dislocation; atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumor. The occipital bone screws are limited to occipital fixation only. Hook components are indicated for use from C1-C7. The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3). They are not intended to be placed in the cervical spine. The Tiger® Occipital-Cervical-Thoracic Spinal Fixation System can be connected to the Tiger® Spine System using the side by side and end to end rod to rod connectors.

Source page: https://510kreport.com/device/K132504
Methodology: https://510kreport.com/methodology