510(k) · Cleared
ClearedBluEX Lumbar 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. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 23, 2024 as substantially equivalent to K213441 (L&K BIOMED Co., Ltd., 2022) and 3 other predicates after a 34-day review. Its family tree reaches back 25 generations to 1984.
- Decided
- Oct 23, 2024
- Review
- 34 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 25 generations to K841189 (1984). 373 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK203531 XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021
- 2 generations backK221719 ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022
- 1 generation backK223474 PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd. · 2023
- This deviceK242829 BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. · 2024
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 7 generations backK160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody…Spineology, Inc. · 2016
- 6 generations backK162879 Elite Expandable Interbody Fusion DeviceSpineology, Inc. · 2017
- 5 generations backK171425 Concorde LiftMedos International SARL · 2017 · Recalled
- 4 generations backK190708 AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019
- 3 generations backK203531 XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021
- 2 generations backK221719 ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022
- 1 generation backK223474 PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd. · 2023
- This deviceK242829 BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −7 | K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion… | Spineology, Inc. | 2016 | — |
| −6 | K162879 | Elite Expandable Interbody Fusion Device | Spineology, Inc. | 2017 | — |
| −5 | K171425 | Concorde Lift | Medos International SARL | 2017 | 2 |
| −4 | K190708 | AccelFix Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2019 | — |
| −3 | K203531 | XYPAN Expandable Lumbar Cage System | Aegis Spine, Inc. | 2021 | — |
| −2 | K221719 | ABTross ALIF Expandable Cage System | Aegis Spine, Inc. | 2022 | — |
| −1 | K223474 | PathLoc-TA Expandable Lumbar Cage System | L&K BIOMED Co., Ltd. | 2023 | — |
| 0 (this device) | K242829 | BluEX Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 20 | 0 |
| 2004 | 38 | 0 |
| 2005 | 24 | 0 |
| 2006 | 14 | 0 |
| 2007 | 17 | 0 |
| 2008 | 40 | 0 |
| 2009 | 29 | 0 |
| 2010 | 24 | 0 |
| 2011 | 27 | 0 |
| 2012 | 20 | 0 |
| 2013 | 20 | 0 |
| 2014 | 14 | 0 |
| 2015 | 11 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K213441 | PathLoc Lumbar Interbody Fusion Cage SystemSummary page 5…r 21 CFR 8 Product Code(s) MAX I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213441 PathLoc Interbody Fusion Cage System MAX K223474 PathLoc-TA Expandable Lumbar Cage System MAX K231680 AccelFix Lumbar Expandable… | 2022 |
| * | K223474 | PathLoc-TA Expandable Lumbar Cage SystemSummary page 5…Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213441 PathLoc Interbody Fusion Cage System MAX K223474 PathLoc-TA Expandable Lumbar Cage System MAX K231680 AccelFix Lumbar Expandable cage System MAX K131612 AnyPlus Peek Cage MAX | D… | 2023 |
| * | K231680 | AccelFix Lumbar Expandable Cage SystemSummary page 5…edicate Trade Name (Primary Predicate is listed first) Product Code K213441 PathLoc Interbody Fusion Cage System MAX K223474 PathLoc-TA Expandable Lumbar Cage System MAX K231680 AccelFix Lumbar Expandable cage System MAX K131612 AnyPlus Peek Cage MAX | Device Description Summary 21 CFR 807.92(a)(4) The BI… | 2023 |
| * | K131612 | Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek CagesSummary page 5…st) Product Code K213441 PathLoc Interbody Fusion Cage System MAX K223474 PathLoc-TA Expandable Lumbar Cage System MAX K231680 AccelFix Lumbar Expandable cage System MAX K131612 AnyPlus Peek Cage MAX | Device Description Summary 21 CFR 807.92(a)(4) The BIuEX Lumbar Expandable Cage System is an interbody f… | 2014 |
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 40 years and passes through 16 companies; a new generation was cleared every 10 months on median.
- 35 of the 373 ancestors have a recall of any class.
- 1 other device also cites its predicate K213441.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
BluEX Lumbar Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. BluEX Lumbar Expandable Cage System is intended for use at either one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of…
Read the full statement (168 words)
BluEX Lumbar Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion.
BluEX Lumbar Expandable Cage System is intended for use at either one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The BluEX Lumbar Expandable Cage System must be used with supplementary internal spinal fixation system that are cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (≥20 lordosis) must be used with at least anterior supplemental fixation.
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/K242829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242829: BluEX Lumbar 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/K242829
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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