510(k) · Cleared
ClearedLucent; Lucent Ti-Bond Systems
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 May 19, 2015 as substantially equivalent to K071724 (Spinal Elements, Inc., 2007) and 2 other predicates after a 126-day review. Its family tree reaches back 4 generations to 2001. 135 later devices descend from it.
- Decided
- May 19, 2015
- Review
- 126 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to P980048 (2001). 8 ancestors in all. 135 later devices descend from it, 10 citing it directly.
- Root · 4 generations backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- 3 generations backK112036 Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011
- 2 generations backK110632 Lucent or Lucent MagnumSpinal Elements, Inc. · 2012 · Recalled
- 1 generation backK122967 LucentSpinal Elements, Inc. · 2013
- This deviceK150061 Lucent; Lucent Ti-Bond SystemsSpinal Elements, Inc. · 2015
- Descendant · cites it directly · 107 of its ownK170235 Lucent®Spinal Elements, Inc. · 2017
- Descendant · cites it directly · 106 of its ownK152011 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
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 135 · See all- K170235Lucent®Spinal Elements, Inc. · 2017 · cites it directly107descendants
- K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc. · 2016 · cites it directly106descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| −3 | K112036 | Calix PC Spinal Implant System | X-Spine Systems, Inc. | 2011 | — |
| −2 | K110632 | Lucent or Lucent Magnum | Spinal Elements, Inc. | 2012 | 1 |
| −1 | K122967 | Lucent | Spinal Elements, Inc. | 2013 | — |
| 0 (this device) | K150061 | Lucent; Lucent Ti-Bond Systems | Spinal Elements, Inc. | 2015 | — |
| +1 | K170235 | Lucent® | Spinal Elements, Inc. | 2017 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 17 | 0 |
| 2023 | 21 | 0 |
| 2024 | 22 | 0 |
| 2025 | 28 | 0 |
| 2026 | 23 | 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? (3)
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 III. PREDICATE DEVICE Primary Predicate Name Lucent® Regulatory Class Class II Submission No K071724 Device Code MAX Predicate Name Lucent Ti-Bond® Regulatory Class… | 2007 |
| * | K110632 | Lucent or Lucent MagnumSummary page 4…ce Code MAX Predicate Name Lucent Ti-Bond® Regulatory Class Class II Submission No K110632 Device Code MAX… | 2012 |
| * | K122967 | LucentSummary page 5…tervertebral Body Fusion Device Predicate Name Lucent® Lateral Regulatory Class Class II Submission No K122967 Device Code MAX IV. DEVICE DESCRIPTION The Lucent® device is an intervertebral body fusion device for… | 2013 |
What descends from it? (135)
See all 13510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170235 | Lucent® | 2017 | 107 |
| K152011 | Lucent Intervertebral Body Fusion Device | 2016 | 106 |
| K181837 | Spinal Elements Ti-Bond coated devices | 2018 | 98 |
| K203254 | Lucent 3D Spinal System | 2021 | 8 |
| K200084 | Zavation IBF System | 2020 | 8 |
| K171657 | ShurFit 2C Lumbar Interbody Fusion System | 2017 | 4 |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System… | 2021 | 1 |
| K183259 | Idys™ TLIF TiVac | 2019 | 1 |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | 2022 | 0 |
| K181096 | Avenue P Cage System | 2019 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K170235 (Spinal Elements, Inc., 2017) has gone furthest, with 107 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. 2015, 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® and Lucent Ti-Bond® are intervertebral body fusion devices 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…
Read the full statement (151 words)
Lucent® and Lucent Ti-Bond® are intervertebral body fusion devices 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).
These devices are 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 these devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150061: Lucent; Lucent Ti-Bond Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150061
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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