510(k) · Cleared
ClearedLucent 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 Dec 26, 2007 after a 27-day review. The FDA summary names no predicate by number. 1 of the 1,022 devices in its family, counting itself, has a Class I recall. 1,021 later devices descend from it.
- Decided
- Dec 26, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
1,021 later devices descend from it, 8 citing it directly. 1 of the 1,022 devices in this family, counting this one, has a Class I recall.
- This deviceK073348 Lucent MagnumSpinal Elements, Inc. · 2007
- Descendant · cites it directly · 788 of its ownK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · cites it directly · 716 of its ownK081968 Modification to LucentSpinal Elements, Inc. · 2008
- Descendant · cites it directly · 708 of its ownK080822 VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · Recalled
- Descendant · cites it directly · 694 of its ownK110632 Lucent or Lucent MagnumSpinal Elements, Inc. · 2012 · Recalled
- Descendant · cites it directly · 615 of its ownK122967 LucentSpinal Elements, Inc. · 2013
Showing 5 of 1,021 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 1,021 · See all- K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc. · 2008 · cites it directly788descendants
- K081968Modification to LucentSpinal Elements, Inc. · 2008 · cites it directly716descendants
- K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · cites it directly708descendants
- K110632Lucent or Lucent MagnumSpinal Elements, Inc. · 2012 · cites it directly694descendants
- K122967LucentSpinal Elements, Inc. · 2013 · cites it directly615descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073348 | Lucent Magnum | Spinal Elements, Inc. | 2007 | — |
| +1 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +1 | K081968 | Modification to Lucent | Spinal Elements, Inc. | 2008 | — |
| +1 | K080822 | VU Apod Intervertabral Body Fusion Device | Theken Spine, LLC | 2008 | 1 |
| +1 | K110632 | Lucent or Lucent Magnum | Spinal Elements, Inc. | 2012 | 1 |
| +1 | K122967 | Lucent | Spinal Elements, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 14 | 0 |
| 2014 | 31 | 0 |
| 2015 | 35 | 0 |
| 2016 | 57 | 0 |
| 2017 | 89 | 0 |
| 2018 | 78 | 0 |
| 2019 | 89 | 0 |
| 2020 | 92 | 0 |
| 2021 | 78 | 1 |
| 2022 | 80 | 0 |
| 2023 | 98 | 0 |
| 2024 | 99 | 0 |
| 2025 | 80 | 0 |
| 2026 | 74 | 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?
The FDA summary names no predicate by number.
What descends from it? (1,021)
See all 1,0218 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space | 2008 | 788 |
| K081968 | Modification to Lucent | 2008 | 716 |
| K080822 | VU Apod Intervertabral Body Fusion Device | 2008 | 708 |
| K110632 | Lucent or Lucent Magnum | 2012 | 694 |
| K122967 | Lucent | 2013 | 615 |
| K133717 | Longbow Spacer System | 2014 | 9 |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System… | 2021 | 1 |
| K081711 | Lucent Magnum+ | 2008 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K071983 (Aesculap Implant Systems, Inc., 2008) has gone furthest, with 788 descendants of its own.
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. 2007, 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?
When used as a vertebral body replacement: When used as a vertebral body replacement, the Lucent Magnum device is intended for use in the thoracic and/or thoracolumbar spine (TL-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e.,, fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for…
Read the full statement (270 words)
When used as a vertebral body replacement:
When used as a vertebral body replacement, the Lucent Magnum device is intended for use in the thoracic and/or thoracolumbar spine (TL-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e.,, fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
When used as an intervertebralbody fusion device:
When used as an intervertebral body fusion device, the Lucent Magnum device is intended for spinal fusion procedures at one or two contiguous levels (L2-SL) 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 of non-operative treatment prior to being treated with the Lucent device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073348: 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/K073348
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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