# K210420: Goblin and Goblin LS Pedicle Screw Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medynus, Inc.
- Decided: Apr 19, 2021 after 67 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: 10 generations back to K990745 (1999). 60 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 5.
- K093294: Revere Stabilization System, Globus Medical, Inc. (2010) Summary page 5.
- K111362: Rexious Spinal Fixation System, Dio Medical Co., Ltd. (2011) Summary page 5.
- K173131: Rexious Spinal Fixation System, Huvexel Co., Ltd. (2017) Summary page 5.
- K160731: LumFix Spinal Fixation Sytem, CG Bio Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K260362: QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) (2026), 0 descendants of its own

## Indications for use
The Goblin and Goblin LS Pedicle Screw Systems are intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: * Degenerative disc disease (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; * Curvatures (i.e., scoliosis, kyphosis and/or lordosis); * Tumor and pseudarthrosis

Source page: https://510kreport.com/device/K210420
Methodology: https://510kreport.com/methodology