510(k) · Cleared
ClearedGSB Global Spinal Balance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 31, 2013 as substantially equivalent to K030383 (Depuyacromed, 2003) and 4 other predicates after a 122-day review. Its family tree reaches back 7 generations to 2004. 82 later devices descend from it.
- Decided
- Oct 31, 2013
- Review
- 122 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K040583 (2004). 53 ancestors in all, the oldest K841189 (1984). 82 later devices descend from it, 9 citing it directly.
- Root · 7 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 4 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 2 generations backK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- 1 generation backK082236 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008
- This deviceK132014 GSB Global Spinal Balance SystemNuvasive, Inc. · 2013
- Descendant · cites it directly · 78 of its ownK142499 Reline SystemNu Vasive, Incorporated · 2014
- Descendant · cites it directly · 77 of its ownK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 67 of its ownK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 48 of its ownK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 41 of its ownK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K142499Reline SystemNu Vasive, Incorporated · 2014 · cites it directly78descendants
- K143684NuVasive Reline SystemNu Vasive, Incorporated · 2015 · cites it directly77descendants
- K160989NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · cites it directly67descendants
- K161014NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · 2 generations on48descendants
- K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018 · 2 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −4 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −2 | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| −1 | K082236 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2008 | — |
| 0 (this device) | K132014 | GSB Global Spinal Balance System | Nuvasive, Inc. | 2013 | — |
| +1 | K142499 | Reline System | Nu Vasive, Incorporated | 2014 | — |
| +1 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| +2 | K161014 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| +2 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 15 | 0 |
| 2024 | 11 | 0 |
| 2025 | 11 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsSummary page 1…cate IDevices The subject GSB Global Spinal Balance S' s/emn is substantially equivalent to the predicate device, DePuv Acronwed Aloss Miami Spinal.S-Ystent (K030383), Aledironic S5ofamnor Danek US A CD !IORIZOft ) Spinal System (K(082236), Interpore Cross International Synergyi Spi… | 2003 |
| * | K082236 | CD Horizon Spinal SystemSummary page 1…lly equivalent to the predicate device, DePuv Acronwed Aloss Miami Spinal.S-Ystent (K030383), Aledironic S5ofamnor Danek US A CD !IORIZOft ) Spinal System (K(082236), Interpore Cross International Synergyi Spial System (K(01 1437). ANulWsive Spheliv Ii Pet/ic/c S5crei' Systeml (K061 778)… | 2008 |
| * | K011437 | Synergy 4.0 MM, 4.5 MM VLS Screws | 2001 |
| * | K061778 | Nuvasive Spherx II SystemSummary page 1…US A CD !IORIZOft ) Spinal System (K(082236), Interpore Cross International Synergyi Spial System (K(01 1437). ANulWsive Spheliv Ii Pet/ic/c S5crei' Systeml (K061 778) and Nul'asive Armada Syswnz (K(091502). D. Device Description The A'uVavive GS/I Global pinal Balance Sva ein (h… | 2006 |
| * | K091502 | Nuvasive Spherx II SystemSummary page 1…36), Interpore Cross International Synergyi Spial System (K(01 1437). ANulWsive Spheliv Ii Pet/ic/c S5crei' Systeml (K061 778) and Nul'asive Armada Syswnz (K(091502). D. Device Description The A'uVavive GS/I Global pinal Balance Sva ein (hereto reIcrenced as the G.SB System) is… | 2009 |
What descends from it? (82)
See all 829 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142499 | Reline System | 2014 | 78 |
| K143684 | NuVasive Reline System | 2015 | 77 |
| K160989 | NuVasive® Reline® System | 2016 | 67 |
| K170126 | NuVasive® Reline® 4.5-5.0 System | 2017 | 39 |
| K223181 | NuVasive Reline System | 2023 | 11 |
| K250908 | Virata Spinal Fixation System | 2025 | 2 |
| K142737 | MAS PLIF Fixation system | 2014 | 1 |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5… | 2026 | 0 |
| K203607 | MOSS VRS Spinal System | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 5 months on median.
- 5 of the 53 ancestors have a recall of any class.
- Of its descendants, K142499 (Nu Vasive, Incorporated, 2014) has gone furthest, with 78 descendants of its own.
- 22 other devices also cite its predicate K030383.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
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…
Read the full statement (222 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132014: GSB Global Spinal Balance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132014
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026