510(k) · Cleared
ClearedLumiVy Lumbar IBF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vy Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Feb 16, 2022 as substantially equivalent to K183049 (Reliance Medical Systems, LLC, 2019) after a 155-day review. Its family tree reaches back 15 generations to 1984. 6 later devices descend from it.
- Decided
- Feb 16, 2022
- Review
- 155 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K841189 (1984). 36 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK173283 Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2018
- 2 generations backK180687 Reliance Lumber IBF SystemReliance Medical Systems · 2018
- 1 generation backK183049 Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2019
- This deviceK212930 LumiVy Lumbar IBF SystemVy Spine, LLC · 2022
- Descendant · cites it directly · 5 of its ownK223412 LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2023
- Descendant · 2 generations on · 3 of its ownK230414 ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023
- Descendant · 3 generations on · 2 of its ownK231836 ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023
- Descendant · cites it directly · 1 of its ownK233807 LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK250773 Luna® Ti Interbody Fusion SystemSpinal Elements, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 11 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 10 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 9 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 7 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 6 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 5 generations backK102313 Patriot Transcontinental M SpacersGlobus Medical, Inc. · 2010
- 4 generations backK160463 Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2016
- 3 generations backK173283 Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2018
- 2 generations backK180687 Reliance Lumber IBF SystemReliance Medical Systems · 2018
- 1 generation backK183049 Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2019
- This deviceK212930 LumiVy Lumbar IBF SystemVy Spine, LLC · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2023 · cites it directly5descendants
- K230414ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023 · 2 generations on3descendants
- K231836ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023 · 3 generations on2descendants
- K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2024 · cites it directly1descendant
- K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −11 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −10 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −9 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −7 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −6 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −5 | K102313 | Patriot Transcontinental M Spacers | Globus Medical, Inc. | 2010 | — |
| −4 | K160463 | Reliance Lumbar IBF System | Reliance Medical Systems, LLC | 2016 | — |
| −3 | K173283 | Reliance Lumbar IBF System | Reliance Medical Systems, LLC | 2018 | — |
| −2 | K180687 | Reliance Lumber IBF System | Reliance Medical Systems | 2018 | — |
| −1 | K183049 | Reliance Lumbar IBF System | Reliance Medical Systems, LLC | 2019 | — |
| 0 (this device) | K212930 | LumiVy Lumbar IBF System | Vy Spine, LLC | 2022 | — |
| +1 | K223412 | LumiVy™ Lumbar IBF System | Vy Spine, LLC | 2023 | — |
| +2 | K230414 | ClariVy™ Cervical IBF System | Vy Spine, LLC | 2023 | — |
| +3 | K231836 | ClariVy™ Cervical IBF System | Vy Spine, LLC | 2023 | — |
| +1 | K233807 | LumiVy™ Lumbar IBF System | Vy Spine, LLC | 2024 | — |
| +2 | K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K183049 | Reliance Lumbar IBF SystemSummary page 4…080 Product Code: MAX Substantial Equivalence The Vy Spine™ LumiVy™ Lumbar IBF System is substantially equivalent to the primary predicate device Reliance Lumbar IBF (K183049). The Vy Spine™ LumiVy™ Lumbar IBF System is equivalent to these commercially available devices in terms of material, intended us… | 2019 |
What descends from it? (6)
2 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 38 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 36 ancestors have a recall of any class.
- Of its descendants, K223412 (Vy Spine, LLC, 2023) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K183049.
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. 2022, 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?
The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device, is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an…
Read the full statement (164 words)
The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device, is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Additional supplemental fixation is not necessary for the LumiVy™ -AS implants if the integrated screws are implanted.
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/K212930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212930: LumiVy Lumbar IBF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212930
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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