510(k) · Cleared
Recalled · Class II · 2014Lucent or Lucent Magnum
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 23, 2012 as substantially equivalent to K071724 (Spinal Elements, Inc., 2007) and 2 other predicates after a 446-day review. Its family tree reaches back 2 generations to 2001. 1 of the 701 devices in its family, counting itself, has a Class I recall. 694 later devices descend from it. It has been recalled once.
- Decided
- May 23, 2012
- Review
- 446 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to P980048 (2001). 6 ancestors in all. 694 later devices descend from it, 12 citing it directly. 1 of the 701 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- 1 generation backK112036 Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011
- This deviceK110632 Lucent or Lucent MagnumSpinal Elements, Inc. · 2012
- Descendant · cites it directly · 615 of its ownK122967 LucentSpinal Elements, Inc. · 2013
- Descendant · cites it directly · 590 of its ownK140319 Coroent TI-C SystemNuvasive, Inc. · 2014
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
Showing 5 of 694 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 694 · See all- K122967LucentSpinal Elements, Inc. · 2013 · cites it directly615descendants
- K140319Coroent TI-C SystemNuvasive, Inc. · 2014 · cites it directly590descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 3 generations on402descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| −1 | K112036 | Calix PC Spinal Implant System | X-Spine Systems, Inc. | 2011 | — |
| 0 (this device) | K110632 | Lucent or Lucent Magnum | Spinal Elements, Inc. | 2012 | — |
| +1 | K122967 | Lucent | Spinal Elements, Inc. | 2013 | — |
| +1 | K140319 | Coroent TI-C System | Nuvasive, Inc. | 2014 | — |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +3 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 8 | 0 |
| 2015 | 13 | 0 |
| 2016 | 26 | 0 |
| 2017 | 44 | 0 |
| 2018 | 43 | 0 |
| 2019 | 54 | 0 |
| 2020 | 75 | 0 |
| 2021 | 58 | 1 |
| 2022 | 64 | 0 |
| 2023 | 81 | 0 |
| 2024 | 87 | 0 |
| 2025 | 76 | 0 |
| 2026 | 63 | 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 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 2…rtebral body fusion device is substantially equivalent to the following cleared devices in indications for use, design, function, and materials used. > Lucent 510(k) K071724 and K073348 > X-Spine Calix PC System (Kl 12036) Performance Data A comparison of the data to mechanical testing performance… | 2007 |
| * | K073348 | Lucent MagnumSummary page 2…fusion device is substantially equivalent to the following cleared devices in indications for use, design, function, and materials used. > Lucent 510(k) K071724 and K073348 > X-Spine Calix PC System (Kl 12036) Performance Data A comparison of the data to mechanical testing performance results of… | 2007 |
| * | K112036 | Calix PC Spinal Implant System Cleared while this submission was under review | 2011 |
What descends from it? (694)
See all 69412 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122967 | Lucent | 2013 | 615 |
| K140319 | Coroent TI-C System | 2014 | 590 |
| K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | 2013 | 251 |
| K143740 | Battalion Universal Spacer System | 2015 | 247 |
| K150061 | Lucent; Lucent Ti-Bond Systems | 2015 | 135 |
| K133205 | Capstone PTC Spinal System, Clydesdale PTC Spinal System | 2014 | 124 |
| K152011 | Lucent Intervertebral Body Fusion Device | 2016 | 106 |
| K181837 | Spinal Elements Ti-Bond coated devices | 2018 | 98 |
| K132596 | Proposed Optimus | 2014 | 5 |
| K182584 | Lucent® XP | 2018 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2014 | Class II | Z-0907-2015 | Labeling False and Misleading | Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions) the content regarding the Ti-Bond coating within the literature is unsubstantiated in context and/or misleading for the… |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K122967 (Spinal Elements, Inc., 2013) has gone furthest, with 615 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. 2012, 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®K and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (TI-L-5) 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 I spondylolisthesis or retrolisthesis at the involved levels. These patients…
Read the full statement (151 words)
Lucent®K and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (TI-L-5) 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 I 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/K110632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110632: Lucent or Lucent Magnum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110632
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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