# K201420: Republic Spine Dark Star Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Republic Spine, LLC
- Decided: Mar 5, 2021 after 280 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: 18 generations back to K040583 (2004). 295 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 298 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181495: Republic Spine Dark Star Spinal System, Republic Spine, LLC (2018) Summary page 4.
- K193100: RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System, OrthoPediatrics Corp. (2020) Summary page 4.
- K180179: Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw, Orthofix, Inc. (2018) Summary page 4.
- K141186: Firebird Spinal Fixation System, Orthofix, Inc. (2015) Summary page 4.
- K171421: VERTICALE® Posterior Spinal Fixation System/VERTICALE® System, Silony Medical GmbH (2018) Summary page 4.

## Most influential descendants
- 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 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: • Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); • Spondylolisthesis; • Trauma (i.e. fracture or dislocation); • Spinal stenosis; • Curvature (i.e. scoliosis, kyphosis, and/or lordosis); • Tumor; • Pseudoarthrosis; and • Failed previous fusion.

Source page: https://510kreport.com/device/K201420
Methodology: https://510kreport.com/methodology