510(k) · Cleared
ClearedEDEN Spinal Fixation MIS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jmt Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 15, 2023 as substantially equivalent to K201788 (Jmt Co., Ltd., 2022) after an 87-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Jun 15, 2023
- Review
- 87 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K950697 (1995). 88 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.
- Root · 11 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 7 generations between
- 3 generations backK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK143110 GALAXY MIS Screw SystemBm Korea · 2015
- 1 generation backK201788 EDEN Spinal Fixation SystemJmt Co., Ltd. · 2022
- This deviceK230762 EDEN Spinal Fixation MIS SystemJmt Co., Ltd. · 2023
Show all 11 generations
- Root · 11 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 10 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 9 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 8 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 7 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 6 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 5 generations backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- 4 generations backK112643 Focus Mis SystemL&K BIOMED Co., Ltd. · 2012
- 3 generations backK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK143110 GALAXY MIS Screw SystemBm Korea · 2015
- 1 generation backK201788 EDEN Spinal Fixation SystemJmt Co., Ltd. · 2022
- This deviceK230762 EDEN Spinal Fixation MIS SystemJmt Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −10 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −9 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −8 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −7 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −6 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −5 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| −4 | K112643 | Focus Mis System | L&K BIOMED Co., Ltd. | 2012 | — |
| −3 | K120140 | Focus Spinal System | L&K BIOMED Co., Ltd. | 2012 | — |
| −2 | K143110 | GALAXY MIS Screw System | Bm Korea | 2015 | — |
| −1 | K201788 | EDEN Spinal Fixation System | Jmt Co., Ltd. | 2022 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K201788 | EDEN Spinal Fixation SystemSummary page 4…Product Code NKB Predicate or legally marketed devices which are substantially equivalent Primary predicate device: K201788, “EDEN Spinal Fixation System”, manufactured by “JMT Co., Ltd.” Device Description The purpose of… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 8 of the 88 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 EDEN Spinal Fixation MIS 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 EDEN Spinal Fixation MIS System can be used in an open approach and a percutaneous approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230762: EDEN Spinal Fixation MIS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230762
Report an extraction error
Are you the manufacturer?
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