510(k) · Cleared
ClearedBluEX Cervical Expandable Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 16, 2026 as substantially equivalent to K180675 (Atlas Spine, Inc., 2018) and 4 other predicates after a 61-day review. Its family tree reaches back 20 generations to 1984. 1 of the 196 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 16, 2026
- Review
- 61 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K841189 (1984). 194 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 196 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 2 generations backK162918 Atlas Spine Expandable Interbody SystemAtlas Spine, Inc. · 2017
- 1 generation backK180675 Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc. · 2018
- This deviceK260840 BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK262489 BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 10 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 9 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 8 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 7 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 6 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 5 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 4 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 3 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 2 generations backK162918 Atlas Spine Expandable Interbody SystemAtlas Spine, Inc. · 2017
- 1 generation backK180675 Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc. · 2018
- This deviceK260840 BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −10 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −9 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −8 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −7 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −6 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −5 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −4 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −3 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −2 | K162918 | Atlas Spine Expandable Interbody System | Atlas Spine, Inc. | 2017 | — |
| −1 | K180675 | Atlas Spine Expandable Cervical Interbody System | Atlas Spine, Inc. | 2018 | — |
| 0 (this device) | K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026 | — |
| +1 | K262489 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 15 | 0 |
| 2005 | 14 | 0 |
| 2006 | 4 | 0 |
| 2007 | 10 | 0 |
| 2008 | 29 | 1 |
| 2009 | 20 | 0 |
| 2010 | 11 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K180675 | Atlas Spine Expandable Cervical Interbody SystemSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K180675 Atlas Spine Expandable Cervical Interbody System ODP K120840… | 2018 |
| * | K120840 | Lexus Cervical Intervertebral Body Fusion Cage SystemSummary page 5…Product Code K180675 Atlas Spine Expandable Cervical Interbody System ODP K120840 LnK Cervical Interbody Fusion Cage System ODP K143360… | 2012 |
| * | K143360 | LnK Cervical Interbody Fusion Cage SystemSummary page 5…ODP K120840 LnK Cervical Interbody Fusion Cage System ODP K143360 LnK Cervical Interbody Fusion Cage System ODP K151677… | 2015 |
| * | K151677 | LnK Cervical Interbody Fusion Cage SystemSummary page 5…ODP K143360 LnK Cervical Interbody Fusion Cage System ODP K151677 LnK Cervical Interbody Fusion Cage System ODP K153517… | 2015 |
| * | K153517 | AnyPlus® Cervical PEEK Cage SystemSummary page 5…ODP K151677 LnK Cervical Interbody Fusion Cage System ODP K153517 AnyPlus® Cervical PEEK Cage System ODP Device Des… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262489 | BluEX Cervical Expandable Cage System | 2026 | 0 |
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 · 5 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 16 companies; a new generation was cleared every 1.0 years on median.
- 24 of the 194 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K262489 (L&K BIOMED Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The BluEX Cervical Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The BluEX Cervical Expandable Cage System is intended for use in anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), resulting in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to…
Read the full statement (123 words)
The BluEX Cervical Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The BluEX Cervical Expandable Cage System is intended for use in anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), resulting in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. The BluEX Cervical Expandable Cage System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. The BluEX Cervical Expandable Cage System is intended to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260840: BluEX Cervical Expandable Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260840
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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