510(k) · Cleared
ClearedGALAXY MIS Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bm Korea · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 24, 2015 as substantially equivalent to K120353 (Bm Korea Co., Ltd., 2012) and 3 other predicates after a 238-day review. Its family tree reaches back 9 generations to 1995. 2 later devices descend from it.
- Decided
- Jun 24, 2015
- Review
- 238 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K950697 (1995). 86 ancestors in all, the oldest K933881 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 5 generations between
- 3 generations backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- 2 generations backK112643 Focus Mis SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- This deviceK143110 GALAXY MIS Screw SystemBm Korea · 2015
- Descendant · cites it directly · 1 of its ownK201788 EDEN Spinal Fixation SystemJmt Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK230762 EDEN Spinal Fixation MIS SystemJmt Co., Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 8 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 7 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 5 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 4 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- 2 generations backK112643 Focus Mis SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- This deviceK143110 GALAXY MIS Screw SystemBm Korea · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −8 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −7 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −5 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −4 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| −2 | K112643 | Focus Mis System | L&K BIOMED Co., Ltd. | 2012 | — |
| −1 | K120140 | Focus Spinal System | L&K BIOMED Co., Ltd. | 2012 | — |
| 0 (this device) | K143110 | GALAXY MIS Screw System | Bm Korea | 2015 | — |
| +1 | K201788 | EDEN Spinal Fixation System | Jmt Co., Ltd. | 2022 | — |
| +2 | K230762 | EDEN Spinal Fixation MIS System | Jmt Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K120353 | Synster Pedicle Screw System Synster Plus Pedicle Screw SystemSummary page 4…Predicate Device: • Primary Predicate Device: - SYNSTER® Pedicle Screw System, SYNSTER® PLUS Pedicle Screw System by BM KOREA Co., Ltd., K120353 • Additional Predicate Device: - AnyPlus Spinal Fixation System by GS Medical Co., Ltd., K091717 - Fo… | 2012 |
| * | K091717 | Any Plus Spinal Fixation SystemSummary page 4…Pedicle Screw System by BM KOREA Co., Ltd., K120353 • Additional Predicate Device: - AnyPlus Spinal Fixation System by GS Medical Co., Ltd., K091717 - Focus Spinal System by L&K Biomed, K112643 and K120140 6. Description: The GALAXY MIS Screw System cons… | 2010 |
| * | K112643 | Focus Mis SystemSummary page 4…K120353 • Additional Predicate Device: - AnyPlus Spinal Fixation System by GS Medical Co., Ltd., K091717 - Focus Spinal System by L&K Biomed, K112643 and K120140 6. Description: The GALAXY MIS Screw System consists of GALAXY MIS SCREW (cannulated BM KOREA CO., LTD… | 2012 |
| * | K120140 | Focus Spinal SystemSummary page 4…• Additional Predicate Device: - AnyPlus Spinal Fixation System by GS Medical Co., Ltd., K091717 - Focus Spinal System by L&K Biomed, K112643 and K120140 6. Description: The GALAXY MIS Screw System consists of GALAXY MIS SCREW (cannulated BM KOREA CO., LTD === Page 5… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201788 | EDEN Spinal Fixation System | 2022 | 1 |
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 20 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 8 of the 86 ancestors have a recall of any class.
- Of its descendants, K201788 (Jmt Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The GALAXY MIS Screw System is intended to provide immobilization and stabilization of the posterior, non-cervical spine as an adjunct to fusion in skeletally mature patients 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, pseudarthrosis, and/or failed previous fusion. The GALAXY MIS Screw System can be used in an open approach and a percutaneous approach with MIS instrumentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143110: GALAXY MIS Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143110
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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