# K091266: Theken Coral Spinal System

- Pathway: 510(k) (Special)
- Applicant: Theken Spine, LLC
- Decided: Jun 10, 2009 after 41 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: 4 generations back to K955348 (1996). 9 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041592: Coral Spinal System, Theken Surgical (2004) Summary page 1.
- K070962: Coral Pedicle Screw System, Theken Spine, LLC (2007) Summary page 1.
- K081414: Modification to Coral Spinal System, Theken Spine, LLC (2008) Summary page 1.
- K080792: K2M Cocr Rod, K2m, Inc. (2008) Summary page 1.
- K070551: Modification to: Pioneer Surgical Technology Quantum Spinal System, Pioneer Surgical Technology (2007) Summary page 1.

## Most influential descendants
- K120047: Coral Spinal System (2012), 14 descendants of its own
- K141222: Nautilus Spinal System and Solstice Oct System (2015), 13 descendants of its own
- K151196: Nautilus Spinal System (2015), 12 descendants of its own
- K191575: ARx Spinal System (2019), 10 descendants of its own
- K200070: ARx Spinal System (2020), 9 descendants of its own

## Indications for use
The CoralTM Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K091266
Methodology: https://510kreport.com/methodology