510(k) · Cleared
ClearedLucent Intervertebral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 9, 2016 as substantially equivalent to K071724 (Spinal Elements, Inc., 2007) and 4 other predicates after a 324-day review. Its family tree reaches back 13 generations to 1984. 106 later devices descend from it.
- Decided
- Jun 9, 2016
- Review
- 324 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K841189 (1984). 32 ancestors in all. 106 later devices descend from it, 6 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 2 generations backK113447 Rise SpacerGlobus Medical, Inc. · 2012
- 1 generation backK123231 Caliber SpacersGlobus Medical, Inc. · 2013
- This deviceK152011 Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc. · 2016
- Descendant · cites it directly · 98 of its ownK181837 Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018
- Descendant · 2 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
- Descendant · 3 generations on · 72 of its ownK200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020
- Descendant · 4 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
- Descendant · 5 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 9 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 8 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 5 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 4 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 3 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 2 generations backK113447 Rise SpacerGlobus Medical, Inc. · 2012
- 1 generation backK123231 Caliber SpacersGlobus Medical, Inc. · 2013
- This deviceK152011 Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc. · 2016
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018 · cites it directly98descendants
- K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 2 generations on93descendants
- K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020 · 3 generations on72descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 4 generations on67descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 5 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −9 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −8 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −5 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −4 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −3 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −2 | K113447 | Rise Spacer | Globus Medical, Inc. | 2012 | — |
| −1 | K123231 | Caliber Spacers | Globus Medical, Inc. | 2013 | — |
| 0 (this device) | K152011 | Lucent Intervertebral Body Fusion Device | Spinal Elements, Inc. | 2016 | — |
| +1 | K181837 | Spinal Elements Ti-Bond coated devices | Spinal Elements, Inc. | 2018 | — |
| +2 | K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | 2019 | — |
| +3 | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC | 2020 | — |
| +4 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
| +5 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 14 | 0 |
| 2023 | 16 | 0 |
| 2024 | 19 | 0 |
| 2025 | 24 | 0 |
| 2026 | 20 | 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? (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 |
|---|---|---|---|
| * | K071724 | LucentSummary page 4…MAX Purpose of this 510(k) This 510(k) seeks clearance for line additions to the Lucent, Lucent Ti-Bond and Lucent Lateral previously cleared for use under K071724 and K150061, K110632, K122967, respectively. Device Description The Lucent® XP device is an intervertebral body fusion device f… | 2007 |
| * | K110632 | Lucent or Lucent MagnumSummary page 4…pose of this 510(k) This 510(k) seeks clearance for line additions to the Lucent, Lucent Ti-Bond and Lucent Lateral previously cleared for use under K071724 and K150061, K110632, K122967, respectively. Device Description The Lucent® XP device is an intervertebral body fusion device for use in lumbar spin… | 2012 |
| * | K122967 | LucentSummary page 4…his 510(k) This 510(k) seeks clearance for line additions to the Lucent, Lucent Ti-Bond and Lucent Lateral previously cleared for use under K071724 and K150061, K110632, K122967, respectively. Device Description The Lucent® XP device is an intervertebral body fusion device for use in lumbar spinal surger… | 2013 |
| * | K150061 | Lucent; Lucent Ti-Bond SystemsSummary page 4…AX Purpose of this 510(k) This 510(k) seeks clearance for line additions to the Lucent, Lucent Ti-Bond and Lucent Lateral previously cleared for use under K071724 and K150061, K110632, K122967, respectively. Device Description The Lucent® XP device is an intervertebral body fusion device for use in lu… | 2015 |
| * | K123231 | Caliber SpacersSummary page 5…e devices cleared in: K071724 – Primary Predicate K093242 – Reference Device K110632 – Additional Predicate K122967 – Additional Predicate K150061 – Additional Predicate K123231 – Additional Predicate Performance Data Performance testing included: Static Compression Testing per ASTM F 2077-14 … | 2013 |
| † | K093242 | Patriot Transcontinental Llif Spacer | 2009 |
What descends from it? (106)
See all 1066 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 32 ancestors have a recall of any class.
- Of its descendants, K181837 (Spinal Elements, Inc., 2018) has gone furthest, with 98 descendants of its own.
- 38 other devices also cite its predicate K071724.
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. 2016, 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?
Lucent intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous…
Read the full statement (148 words)
Lucent intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152011 · printed Nov 3, 2026
Cite this page
510(k) Report. “K152011: Lucent Intervertebral Body Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152011
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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