510(k) · Cleared
ClearedLEO Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZheJiang Decans Medical Devices Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 29, 2026 as substantially equivalent to K113666 (Stryker Spine, 2012) and 1 other predicate after a 260-day review. Its family tree reaches back 31 generations to 1984. 1 of the 839 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 29, 2026
- Review
- 260 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 31 generations to K841189 (1984). 838 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 839 devices in this family, counting this one, has a Class I recall.
- Root · 31 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 27 generations between
- 3 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 2 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 1 generation backK223494 CD Horizon Spinal SystemMedtronic · 2023
- This deviceK252542 LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd. · 2026
Show all 31 generations
- Root · 31 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 30 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 29 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 28 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 27 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 26 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 25 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 24 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 23 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 22 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 21 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 20 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 19 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 18 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 17 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 16 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 15 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 14 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 13 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 12 generations backK160955 Tritanium® PL CageStryker · 2016
- 11 generations backK162262 Tritanium® PL CageStryker · 2016
- 10 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 9 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 8 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 7 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 6 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 5 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 4 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 3 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 2 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 1 generation backK223494 CD Horizon Spinal SystemMedtronic · 2023
- This deviceK252542 LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd. · 2026
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −31 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −30 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −29 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −28 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −27 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −26 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −25 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −24 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −23 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −22 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −21 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −20 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −19 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −18 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −17 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −16 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −15 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −14 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −13 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −12 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −11 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −10 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −9 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −8 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −7 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −6 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −5 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −4 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −3 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −2 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| −1 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| 0 (this device) | K252542 | LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 10 | 0 |
| 1996 | 10 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 14 | 0 |
| 2000 | 19 | 0 |
| 2001 | 29 | 0 |
| 2002 | 22 | 0 |
| 2003 | 34 | 0 |
| 2004 | 57 | 0 |
| 2005 | 49 | 0 |
| 2006 | 34 | 0 |
| 2007 | 30 | 0 |
| 2008 | 64 | 1 |
| 2009 | 46 | 0 |
| 2010 | 39 | 0 |
| 2011 | 54 | 0 |
| 2012 | 38 | 0 |
| 2013 | 41 | 0 |
| 2014 | 45 | 0 |
| 2015 | 44 | 0 |
| 2016 | 26 | 0 |
| 2017 | 28 | 0 |
| 2018 | 9 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K113666 | Xia 3 Spinal SystemSummary page 5…Manufacturer Stryker Spine Trade name XIA® 3 Spinal System 510(K) number K113666 Primary Predicate Regulatory Class II/III Device Regulation Number 888.307… | 2012 |
| * | K223494 | CD Horizon Spinal SystemSummary page 5…urer Medtronic Sofamor Danek, USA Inc. Trade name CD HORIZON Legacy Spinal System 510(K) number K223494 Additional Predicate Regulatory Class II Device Regulation Number 888.3070… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 18 companies; a new generation was cleared every 9 months on median.
- 89 of the 838 ancestors have a recall of any class; 1 has a Class I recall.
- 20 other devices also cite its predicate K113666.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 LEO Spinal System is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non-pedicle fixation system, the LEO Spinal System is intended as an adjunct to fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative disc disease (DDD) (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, Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), Tumor, Pseudoarthrosis, Failed previous fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252542: LEO Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252542
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026