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. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Feb 13, 2009 as substantially equivalent to K071724 (Spinal Elements, Inc., 2007) and 2 other predicates after an 81-day review. Its family tree reaches back 11 generations to 1984. 1 of the 878 devices in its family, counting itself, has a Class I recall. 834 later devices descend from it.
- Decided
- Feb 13, 2009
- Review
- 81 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 43 ancestors in all. 834 later devices descend from it, 10 citing it directly. 1 of the 878 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- This deviceK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- Descendant · cites it directly · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · 2 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- Descendant · 3 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · cites it directly · 480 of its ownK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
- Descendant · 4 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- This deviceK083475 Lucent MagnumSpinal Elements, Inc. · 2009
Showing 5 of 834 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 834 · See all- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · cites it directly744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 2 generations on696descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 3 generations on588descendants
- K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010 · cites it directly480descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 4 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −1 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| 0 (this device) | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| +1 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +2 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| +3 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +1 | K101310 | VU Apod Intervertebral Body Fusion Device | Theken Spine, LLC | 2010 | — |
| +4 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 12 | 0 |
| 2015 | 23 | 0 |
| 2016 | 42 | 0 |
| 2017 | 54 | 0 |
| 2018 | 62 | 0 |
| 2019 | 71 | 0 |
| 2020 | 93 | 0 |
| 2021 | 70 | 1 |
| 2022 | 73 | 0 |
| 2023 | 86 | 0 |
| 2024 | 92 | 0 |
| 2025 | 76 | 0 |
| 2026 | 66 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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…as shown to be substantially equivalent in indications for use, general design features, function, and materials to the following predicates: Lucent® by Spinal Elements (K071724), STALIF TT™ by Surgacraft (K073109) and Solitaire™ by Biomet Spine (K081395). SEWICEg » (23 iy _/(C DEPARTMENT… | 2007 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 2…ent in indications for use, general design features, function, and materials to the following predicates: Lucent® by Spinal Elements (K071724), STALIF TT™ by Surgacraft (K073109) and Solitaire™ by Biomet Spine (K081395). SEWICEg » (23 iy _/(C DEPARTMENT OF HEALTH & HUMAN SERVICES Public He… | 2008 |
| * | K081395 | Solitaire Peek-Optima Anterior Spinal SystemSummary page 2…n features, function, and materials to the following predicates: Lucent® by Spinal Elements (K071724), STALIF TT™ by Surgacraft (K073109) and Solitaire™ by Biomet Spine (K081395). SEWICEg » (23 iy _/(C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service > *0 hd & < z 3 , ¢/ ', “… | 2008 |
What descends from it? (834)
See all 83410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100043 | Coroent XLR Standalone System | 2010 | 744 |
| K101310 | VU Apod Intervertebral Body Fusion Device | 2010 | 480 |
| K092211 | Chesapeake Spinal System | 2010 | 450 |
| K120031 | Chesapeake Spinal System | 2012 | 334 |
| K203742 | IdentiTi ALIF Standalone Interbody System | 2021 | 59 |
| K201671 | A-Link Z | 2021 | 25 |
| K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion System | 2022 | 3 |
| K240126 | ProAM ALIF System | 2024 | 2 |
| K253559 | Ventana™ A Anterior Lumbar Interbody System | 2026 | 0 |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | 2025 | 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?
- The line of descent spans 25 years and passes through 10 companies; a new generation was cleared every 9 months on median.
- 6 of the 43 ancestors have a recall of any class.
- Of its descendants, K100043 (Nuvasive, Inc., 2010) has gone furthest, with 744 descendants of its own.
- 38 other devices also cite its predicate K071724.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
Magnum+ is a stand alone device intended to be used with bone screws. If the physician chooses to use fewer than the maximum number of screws accommodated by the device, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability When used as a vertebral body replacement: When used as a vertebral body replacement, the device is intended for use in the thoracic and/or…
Read the full statement (238 words)
Magnum+ is a stand alone device intended to be used with bone screws. If the physician chooses to use fewer than the maximum number of screws accommodated by the device, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability
When used as a vertebral body replacement:
When used as a vertebral body replacement, the device is intended for use in the thoracic and/or thoracolumbar spine (T1-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).
The interior of the spacer can be packed with allograft or autograft.
When used as an intervertebral body fusion device:
Lucent Magnum+ is an intervertebral body fusion device 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 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 device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K083475 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083475: Lucent Magnum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083475
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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