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 Jan 6, 2023 as substantially equivalent to K212930 (Vy Spine, LLC, 2022) and 7 other predicates after a 58-day review. Its family tree reaches back 22 generations to 1984. 5 later devices descend from it.
- Decided
- Jan 6, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 22 generations to K841189 (1984). 304 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 3 citing it directly.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- 2 generations backK192132 SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · Recalled
- 1 generation backK193636 SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation · 2020
- This deviceK223412 LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2023
- Descendant · cites it directly · 3 of its ownK230414 ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023
- Descendant · 2 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 · cites it directly · 0 of its ownK250773 Luna® Ti Interbody Fusion SystemSpinal Elements, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241783 FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC · 2025
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 12 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 11 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 10 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 9 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 8 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 7 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 6 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 5 generations backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- 4 generations backK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
- 3 generations backK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- 2 generations backK192132 SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · Recalled
- 1 generation backK193636 SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation · 2020
- This deviceK223412 LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2023
Most influential descendants
Showing 5 of 5 · See all- K230414ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023 · cites it directly3descendants
- K231836ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023 · 2 generations on2descendants
- K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2024 · cites it directly1descendant
- K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc. · 2026 · cites it directly0descendants
- K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −12 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −11 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −10 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −9 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −8 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −7 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −6 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −5 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| −4 | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016 | — |
| −3 | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura… | SeaSpine Orthopedics Corporation | 2017 | — |
| −2 | K192132 | SeaSpine Beachside System | SeaSpine Orthopedics Corporation | 2019 | 1 |
| −1 | K193636 | SeaSpine Reef TH System | SeaSpine Orthopedics Corporation | 2020 | — |
| 0 (this device) | K223412 | LumiVy™ Lumbar IBF System | Vy Spine, LLC | 2023 | — |
| +1 | K230414 | ClariVy™ Cervical IBF System | Vy Spine, LLC | 2023 | — |
| +2 | K231836 | ClariVy™ Cervical IBF System | Vy Spine, LLC | 2023 | — |
| +1 | K233807 | LumiVy™ Lumbar IBF System | Vy Spine, LLC | 2024 | — |
| +1 | K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026 | — |
| +2 | K241783 | FortiVy™ OsteoVy™ Lumbar IBF | Vy Spine, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 19 | 0 |
| 2004 | 37 | 0 |
| 2005 | 22 | 0 |
| 2006 | 13 | 0 |
| 2007 | 17 | 0 |
| 2008 | 35 | 0 |
| 2009 | 21 | 0 |
| 2010 | 16 | 0 |
| 2011 | 18 | 0 |
| 2012 | 11 | 0 |
| 2013 | 13 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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? (8)
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 |
|---|---|---|---|
| * | K212930 | LumiVy Lumbar IBF SystemSummary page 4…MAX Substantial Equivalence The LumiVy™ NanoVy™ Ti Lumbar IBF System is substantially equivalent to the primary predicate device LumiVy™ Lumbar IBF System (K212930) and the secondary predicate SeaSpine NanoMetalene Spacer System (K200879, K193636, K192132, K181079, K173606, K173260, K142488).… | 2022 |
| * | K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSummary page 4…F System is substantially equivalent to the primary predicate device LumiVy™ Lumbar IBF System (K212930) and the secondary predicate SeaSpine NanoMetalene Spacer System (K200879, K193636, K192132, K181079, K173606, K173260, K142488). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalent to these commercia… | 2020 |
| * | K193636 | SeaSpine Reef TH SystemSummary page 4…is substantially equivalent to the primary predicate device LumiVy™ Lumbar IBF System (K212930) and the secondary predicate SeaSpine NanoMetalene Spacer System (K200879, K193636, K192132, K181079, K173606, K173260, K142488). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalent to these commercially avail… | 2020 |
| * | K192132 | SeaSpine Beachside SystemSummary page 4…ntially equivalent to the primary predicate device LumiVy™ Lumbar IBF System (K212930) and the secondary predicate SeaSpine NanoMetalene Spacer System (K200879, K193636, K192132, K181079, K173606, K173260, K142488). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalent to these commercially available devi… | 2019 |
| * | K181079 | SeaSpine Regatta Lateral SystemSummary page 4…quivalent to the primary predicate device LumiVy™ Lumbar IBF System (K212930) and the secondary predicate SeaSpine NanoMetalene Spacer System (K200879, K193636, K192132, K181079, K173606, K173260, K142488). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalent to these commercially available devices in te… | 2018 |
| * | K173606 | SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…Summary page 4…to the primary predicate device LumiVy™ Lumbar IBF System (K212930) and the secondary predicate SeaSpine NanoMetalene Spacer System (K200879, K193636, K192132, K181079, K173606, K173260, K142488). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalent to these commercially available devices in terms of ma… | 2018 |
| * | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…Summary page 4…rimary predicate device LumiVy™ Lumbar IBF System (K212930) and the secondary predicate SeaSpine NanoMetalene Spacer System (K200879, K193636, K192132, K181079, K173606, K173260, K142488). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalent to these commercially available devices in terms of material, i… | 2017 |
| * | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Summary page 4…edicate device LumiVy™ Lumbar IBF System (K212930) and the secondary predicate SeaSpine NanoMetalene Spacer System (K200879, K193636, K192132, K181079, K173606, K173260, K142488). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalent to these commercially available devices in terms of material, intended u… | 2014 |
What descends from it? (5)
3 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 39 years and passes through 16 companies; a new generation was cleared every 1.0 years on median.
- 28 of the 304 ancestors have a recall of any class.
- Of its descendants, K230414 (Vy Spine, LLC, 2023) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K212930.
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. 2023, 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 LumiVym Lumbar IBF System 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 LumiVym Lumbar IBF System is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to…
Read the full statement (144 words)
The LumiVym Lumbar IBF System 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 LumiVym Lumbar IBF System 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 LumiVyTM -AS implants if the integrated screws are implanted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223412 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223412: LumiVy™ Lumbar IBF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223412
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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