510(k) Report

510(k) · Cleared

Cleared

LumiVy™ Lumbar IBF System

K233807510(k) TraditionalCleared Sep 24, 2024300-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vy Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Sep 24, 2024 as substantially equivalent to K212930 (Vy Spine, LLC, 2022) and 6 other predicates after a 300-day review. Its family tree reaches back 25 generations to 1984. 1 later device descends from it.

Decided
Sep 24, 2024
Review
300 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
7

Its longest line of descent runs back 25 generations to K841189 (1984). 416 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2022: 1 other ancestor2021: 1 other ancestor2020: 1 other ancestor2017: 5 other ancestors2019: 1 other ancestor2018: 4 other ancestors2014: 14 other ancestors2010: 25 other ancestors2016: 4 other ancestors2015: 11 other ancestors2013: 25 other ancestors2012: 22 other ancestors2011: 27 other ancestors2009: 33 other ancestors2008: 42 other ancestors2006: 13 other ancestors2005: 26 other ancestors2007: 19 other ancestors2004: 39 other ancestors2003: 23 other ancestors2001: 13 other ancestors1999: 4 other ancestors1996: 7 other ancestors2002: 15 other ancestors2000: 5 other ancestors1997: 1 other ancestor1995: 1 other ancestor1993: 2 other ancestors1990: 1 other ancestor1998: 2 other ancestors1992: 2 other ancestors1980: 1 other ancestor1979: 1 other ancestor2025: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007×4: 4 generations cleared close together, K072120 (2007), K080083 (2008), K073109 (2008), K081849 (2008) K091301 · Life Spine Stand-Alone Spacer System · Life Spine · 2009K100802 · Aesculap Implant Systems Sibd Spinal System · Aesculap Implant Systems, Inc. · 2010K111122 · Aesculap Sibd XP Spinal System · Aesculap Implant Systems, Inc. · 2011K141942 · Midline II TI · Centinel Spine, Inc. · 2014K150643 · Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti · Centinel Spine, Inc. · 2015×2: 2 generations cleared close together, K161379 (2016), K162351 (2016) K173260 · SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System · SeaSpine Orthopedics Corporation · 2017×2: 2 generations cleared close together, K192132 (2019), K193636 (2020) ×3: 3 generations cleared close together, K223412 (2023), K230414 (2023), K231836 (2023) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 8 other ancestors3 generations back: 30 other ancestors4 generations back: 40 other ancestors5 generations back: 67 other ancestors6 generations back: 79 other ancestors7 generations back: 74 other ancestors8 generations back: 55 other ancestors9 generations back: 20 other ancestors10 generations back: 11 other ancestors11 generations back: 2 other ancestors12 generations back: 1 other ancestor 1 generation forward: 1 descendant K231836 · ClariVy™ Cervical IBF System · Vy Spine, LLC · 2023K230414 · ClariVy™ Cervical IBF System · Vy Spine, LLC · 2023K223412 · LumiVy™ Lumbar IBF System · Vy Spine, LLC · 2023K193636 · SeaSpine Reef TH System · SeaSpine Orthopedics Corporation · 2020K192132 · SeaSpine Beachside System · SeaSpine Orthopedics Corporation · 2019 · recalledK173260 · SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System · SeaSpine Orthopedics Corporation · 2017K162351 · SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device · SeaSpine Orthopedics Corporation · 2016K161379 · ELSA Spacers · Globus Medical, Inc. · 2016K150643 · Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti · Centinel Spine, Inc. · 2015K141942 · Midline II TI · Centinel Spine, Inc. · 2014K111122 · Aesculap Sibd XP Spinal System · Aesculap Implant Systems, Inc. · 2011K100802 · Aesculap Implant Systems Sibd Spinal System · Aesculap Implant Systems, Inc. · 2010K091301 · Life Spine Stand-Alone Spacer System · Life Spine · 2009K081849 · Blackstone Pillar SA Partial Vertebral Body Replacement Device · Blackstone Medical, Inc. · 2008 · recalledK073109 · Stalif TT Intervertebral Body Fusion System · Surgicraft, Ltd. · 2008K080083 · Intrepid Spinal System · Medtronic Sofamor Danek · 2008 · recalledK072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−25−20−15−10−50
  1. Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 21 generations between
  3. 3 generations backK223412 LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2023
  4. 2 generations backK230414 ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023
  5. 1 generation backK231836 ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023
  6. This deviceK233807 LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2024
  7. Descendant · cites it directly · 0 of its ownK241783 FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC · 2025
Show all 25 generations
  1. Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 16 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  11. 15 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  12. 14 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
  13. 13 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
  14. 12 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
  15. 11 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
  16. 10 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
  17. 9 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
  18. 8 generations backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
  19. 7 generations backK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
  20. 6 generations backK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
  21. 5 generations backK192132 SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · Recalled
  22. 4 generations backK193636 SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation · 2020
  23. 3 generations backK223412 LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2023
  24. 2 generations backK230414 ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023
  25. 1 generation backK231836 ClariVy™ Cervical IBF SystemVy Spine, LLC · 2023
  26. This deviceK233807 LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−25K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−24K990148Stackable Cage SystemDepuy Motech Acromed1999—
−23K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−22K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−21K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−20K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−19K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−18K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−17K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−16K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088
−15K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008—
−14K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20081
−13K091301Life Spine Stand-Alone Spacer SystemLife Spine2009—
−12K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010—
−11K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011—
−10K141942Midline II TICentinel Spine, Inc.2014—
−9K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015—
−8K161379ELSA SpacersGlobus Medical, Inc.2016—
−7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation2016—
−6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura…SeaSpine Orthopedics Corporation2017—
−5K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation20191
−4K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation2020—
−3K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC2023—
−2K230414ClariVy™ Cervical IBF SystemVy Spine, LLC2023—
−1K231836ClariVy™ Cervical IBF SystemVy Spine, LLC2023—
0 (this device)K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC2024—
+1K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199010
199220
199320
199510
199670
199710
199820
199940
200050
2001130
2002150
2003230
2004390
2005260
2006130
2007190
2008420
2009330
2010250
2011270
2012220
2013250
2014140
2015110
201640
201750
201840
201910
202010
202110
202210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K233807, 1984–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K212930LumiVy Lumbar IBF System
Summary page 5
…MAX, OVD Substantial Equivalence The LumiVy™ NanoVy™ Ti Lumbar IBF System is substantially equivalent to the primary predicate device LumiVy™ Lumbar IBF System (K212930, K223412) and the secondary predicate devices ClariVy OsteoVy PEKK (K212715, K230414, K231836), RTI FortiLink (K172343), and SeaS…
Vy Spine, LLC2022—
*K223412LumiVy™ Lumbar IBF System
Summary page 5
…AX, OVD Substantial Equivalence The LumiVy™ NanoVy™ Ti Lumbar IBF System is substantially equivalent to the primary predicate device LumiVy™ Lumbar IBF System (K212930, K223412) and the secondary predicate devices ClariVy OsteoVy PEKK (K212715, K230414, K231836), RTI FortiLink (K172343), and SeaSpine Meri…
Vy Spine, LLC2023—
*K212715Vy Spine ClariVy Cervical IBF System
Summary page 5
…System is substantially equivalent to the primary predicate device LumiVy™ Lumbar IBF System (K212930, K223412) and the secondary predicate devices ClariVy OsteoVy PEKK (K212715, K230414, K231836), RTI FortiLink (K172343), and SeaSpine Meridian System (K200879). The LumiVy™ NanoVy™ Ti Lumbar IBF System is…
Vy Spine, LLC2021—
*K230414ClariVy™ Cervical IBF System
Summary page 5
…substantially equivalent to the primary predicate device LumiVy™ Lumbar IBF System (K212930, K223412) and the secondary predicate devices ClariVy OsteoVy PEKK (K212715, K230414, K231836), RTI FortiLink (K172343), and SeaSpine Meridian System (K200879). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalen…
Vy Spine, LLC2023—
*K231836ClariVy™ Cervical IBF System
Summary page 5
…ially equivalent to the primary predicate device LumiVy™ Lumbar IBF System (K212930, K223412) and the secondary predicate devices ClariVy OsteoVy PEKK (K212715, K230414, K231836), RTI FortiLink (K172343), and SeaSpine Meridian System (K200879). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalent to thes…
Vy Spine, LLC2023—
*K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
Summary page 5
…rimary predicate device LumiVy™ Lumbar IBF System (K212930, K223412) and the secondary predicate devices ClariVy OsteoVy PEKK (K212715, K230414, K231836), RTI FortiLink (K172343), and SeaSpine Meridian System (K200879). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalent to these commercially available…
Rti Surgical, Inc.2017—
*K200879SeaSpine Meridian System, SeaSpine Regatta Lateral System
Summary page 5
…BF System (K212930, K223412) and the secondary predicate devices ClariVy OsteoVy PEKK (K212715, K230414, K231836), RTI FortiLink (K172343), and SeaSpine Meridian System (K200879). The LumiVy™ NanoVy™ Ti Lumbar IBF System is equivalent to these commercially available devices in terms of material, intended u…
SeaSpine Orthopedics Corporation2020—

Also cleared against K212930: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250

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 40 years and passes through 16 companies; a new generation was cleared every 11 months on median.
  • 45 of the 416 ancestors have a recall of any class.
  • Of its descendants, K241783 (Vy Spine, LLC, 2025) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K212930.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The LumiVy™ 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 LumiVy™ 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 (178 words)

The LumiVy™ 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 LumiVy™ 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.

Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.

Additional supplemental fixation is not necessary for the LumiVy™ -AS implants if the integrated screws are implanted for cages with a lordosis of less than or equal to 20°.

Indications for use as stated in the FDA summary.

Also cleared against K212930

1 other device cites the same predicate.

  • K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC · 2023

More from Vy Spine, LLC

21 FDA decisions under this applicant name. See the company

  • K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC · 2026
  • K253432DiversiVy™ Facet Screw SystemVy Spine, LLC · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC · 2025
  • K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2024

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K233807 · printed Nov 6, 2026

Cite this page

510(k) Report. “K233807: 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/K233807

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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