# K181495: Republic Spine Dark Star Spinal System

- Pathway: 510(k) (Special)
- Applicant: Republic Spine, LLC
- Decided: Jul 25, 2018 after 49 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: 11 generations back to K853033 (1985). 64 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150283: Republic Spine Dark Star Spinal System, Republic Spine, LLC (2015) Summary page 4.

## Most influential descendants
- K201420: Republic Spine Dark Star Spinal System (2021), 2 descendants of its own
- K223096: Dark Star Deformity Pedicle Screw System (2023), 1 descendant of its own
- K231443: Mini-OSTEO Pedicle Fixation System (2023), 0 descendants of its own

## Indications for use
The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle rigid fixation of the spine 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 the thoracic, lumbar, and sacral spine (T1-S1): Degenerative Disc Disease (DDD); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal stenosis; Curvatures (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion

Source page: https://510kreport.com/device/K181495
Methodology: https://510kreport.com/methodology