510(k) · Cleared
ClearedLucent 3D Spinal System
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 Mar 26, 2021 as substantially equivalent to K150061 (Spinal Elements, Inc., 2015) and 1 other predicate after a 142-day review. Its family tree reaches back 5 generations to 2001. 8 later devices descend from it.
- Decided
- Mar 26, 2021
- Review
- 142 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to P980048 (2001). 10 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 5 generations backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- 4 generations backK112036 Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011
- 3 generations backK110632 Lucent or Lucent MagnumSpinal Elements, Inc. · 2012 · Recalled
- 2 generations backK122967 LucentSpinal Elements, Inc. · 2013
- 1 generation backK150061 Lucent; Lucent Ti-Bond SystemsSpinal Elements, Inc. · 2015
- This deviceK203254 Lucent 3D Spinal SystemSpinal Elements, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK222833 Ventana™ C Spinal SystemSpinal Elements, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 3 generations on · 2 of its ownK241467 Stable-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · cites it directly · 1 of its ownK231252 Ventana™ L Spinal SystemSpinal Elements, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK261279 DeltaNEC Interbody SystemNexus Spine · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K222833Ventana™ C Spinal SystemSpinal Elements, Inc. · 2023 · cites it directly4descendants
- K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 2 generations on3descendants
- K241467Stable-C Interbody SystemNexus Spine, LLC · 2024 · 3 generations on2descendants
- K231252Ventana™ L Spinal SystemSpinal Elements, Inc. · 2023 · cites it directly1descendant
- K261279DeltaNEC Interbody SystemNexus Spine · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| −4 | K112036 | Calix PC Spinal Implant System | X-Spine Systems, Inc. | 2011 | — |
| −3 | K110632 | Lucent or Lucent Magnum | Spinal Elements, Inc. | 2012 | 1 |
| −2 | K122967 | Lucent | Spinal Elements, Inc. | 2013 | — |
| −1 | K150061 | Lucent; Lucent Ti-Bond Systems | Spinal Elements, Inc. | 2015 | — |
| 0 (this device) | K203254 | Lucent 3D Spinal System | Spinal Elements, Inc. | 2021 | — |
| +1 | K222833 | Ventana™ C Spinal System | Spinal Elements, Inc. | 2023 | — |
| +2 | K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +3 | K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +1 | K231252 | Ventana™ L Spinal System | Spinal Elements, Inc. | 2023 | — |
| +4 | K261279 | DeltaNEC Interbody System | Nexus Spine | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K150061 | Lucent; Lucent Ti-Bond SystemsSummary page 5…ally equivalent in indications for use, surgical technique, design features, manufacturing methods and raw materials to the following predicate devices: Lucent® devices (K150061): Primary Predicate OmegaLIF devices (K150395): Additional Predicate Technological Characteristics The subject device was establ… | 2015 |
| * | K150395 | Omega LIF SystemSummary page 5…al technique, design features, manufacturing methods and raw materials to the following predicate devices: Lucent® devices (K150061): Primary Predicate OmegaLIF devices (K150395): Additional Predicate Technological Characteristics The subject device was established as substantially equivalent to another p… | 2015 |
What descends from it? (8)
3 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 20 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K222833 (Spinal Elements, Inc., 2023) has gone furthest, with 4 descendants of its own.
- 9 other devices also cite its predicate K150061.
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. 2021, 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® 3D 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…
Read the full statement (159 words)
Lucent® 3D 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).
These devices are 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 autograft or allogenic bone graft comprised of cancellous and/or corticocancellous 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/K203254 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203254: Lucent 3D Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203254
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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