# K132014: GSB Global Spinal Balance System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Oct 31, 2013 after 122 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: 7 generations back to K040583 (2004). 53 ancestors in all.
82 later devices descend from it; 9 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 1.
- K082236: CD Horizon Spinal System, Medtronic Sofamor Danek (2008) Summary page 1.
- K011437: Synergy 4.0 MM, 4.5 MM VLS Screws, Interpore Cross Intl. (2001)
- K061778: Nuvasive Spherx II System, Nuvasive, Inc. (2006) Summary page 1.
- K091502: Nuvasive Spherx II System, Nuvasive, Inc. (2009) Summary page 1.

## Most influential descendants
- K142499: Reline System (2014), 78 descendants of its own
- K143684: NuVasive Reline System (2015), 77 descendants of its own
- K160989: NuVasive® Reline® System (2016), 67 descendants of its own
- K161014: NuVasive® Reline® System (2016), 48 descendants of its own
- K180498: NuVasive Reline Fenestrated Screws, High V+ Bone Cement (2018), 41 descendants of its own

## Indications for use
When used as a pedicle screw fixation system, the NuVash'e GSB Global Spinal Balance System is intended 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 posterior thoracic, lumbar, and sacral spine: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and/or failed previous fusion (pseudoarthrosis). The NuVasive GSB Global Spinal Balance System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S I vertebra! joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anerolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive GSB Global Spinal Balance System is also intended for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, Spondylolisthesis, spinal deformities, fracture, pseudoarthosis, tumor resection, and/or failed previous fusion.

Source page: https://510kreport.com/device/K132014
Methodology: https://510kreport.com/methodology