510(k) · Cleared
ClearedLuna Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benvenue Medical, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 20, 2014 as substantially equivalent to K130254 (Nlt Spine, Ltd., 2013) and 6 other predicates after a 118-day review. Its family tree reaches back 12 generations to 1984. 5 later devices descend from it.
- Decided
- Nov 20, 2014
- Review
- 118 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K841189 (1984). 53 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 2 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 1 generation backK112095 Acculif TL-Peek Ibf CageCoalign Innovations, Inc. · 2011
- This deviceK142023 Luna Interbody SystemBenvenue Medical, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK162431 Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK183560 Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK193172 Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK250773 Luna® Ti Interbody Fusion SystemSpinal Elements, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK172019 Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd. · 2017
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 8 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 4 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 3 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 2 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 1 generation backK112095 Acculif TL-Peek Ibf CageCoalign Innovations, Inc. · 2011
- This deviceK142023 Luna Interbody SystemBenvenue Medical, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. · 2016 · cites it directly3descendants
- K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc. · 2019 · 2 generations on2descendants
- K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc. · 2020 · 3 generations on1descendant
- K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc. · 2026 · 3 generations on0descendants
- K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −8 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −4 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −3 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −2 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −1 | K112095 | Acculif TL-Peek Ibf Cage | Coalign Innovations, Inc. | 2011 | — |
| 0 (this device) | K142023 | Luna Interbody System | Benvenue Medical, Inc. | 2014 | — |
| +1 | K162431 | Luna 3D Interbody Fusion System | Benvenue Medical, Inc. | 2016 | — |
| +2 | K183560 | Luna 3D GEN2 Interbody Fusion System | Benvenue Medical, Inc. | 2019 | — |
| +3 | K193172 | Luna XD Ti Interbody Fusion System | Benvenue Medical, Inc. | 2020 | — |
| +3 | K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026 | — |
| +1 | K172019 | Brisbane ALIF Device, Gladstone ALIF Device | Signature Orthopaedics Pty, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130254 | Prow FusionSummary page 5…rison: Comparative information presented in the 510(k) supports the substantial equivalence of the Luna Interbody System to the primary predicate of the NLT Prow Fusion (K130254) and other predicates, including R Tree Innovations Epicage (K092901), SeaSpine Hollywood (K082310), Spinal Elements Lucent (K122… | 2013 |
| * | K092901 | Epicage Interbody Fusion DeviceSummary page 5…ubstantial equivalence of the Luna Interbody System to the primary predicate of the NLT Prow Fusion (K130254) and other predicates, including R Tree Innovations Epicage (K092901), SeaSpine Hollywood (K082310), Spinal Elements Lucent (K122967, K071724) and CoAlign Innovations AccuLIF TL-PEEK Cage (K112095 a… | 2010 |
| * | K082310 | Hollywood, Pacifica, Redondo, VenturaSummary page 5…Luna Interbody System to the primary predicate of the NLT Prow Fusion (K130254) and other predicates, including R Tree Innovations Epicage (K092901), SeaSpine Hollywood (K082310), Spinal Elements Lucent (K122967, K071724) and CoAlign Innovations AccuLIF TL-PEEK Cage (K112095 and K093669). Comparisons were… | 2008 |
| * | K122967 | LucentSummary page 5…ry predicate of the NLT Prow Fusion (K130254) and other predicates, including R Tree Innovations Epicage (K092901), SeaSpine Hollywood (K082310), Spinal Elements Lucent (K122967, K071724) and CoAlign Innovations AccuLIF TL-PEEK Cage (K112095 and K093669). Comparisons were designed to show the indications,… | 2013 |
| * | K071724 | LucentSummary page 5…ate of the NLT Prow Fusion (K130254) and other predicates, including R Tree Innovations Epicage (K092901), SeaSpine Hollywood (K082310), Spinal Elements Lucent (K122967, K071724) and CoAlign Innovations AccuLIF TL-PEEK Cage (K112095 and K093669). Comparisons were designed to show the indications, intended… | 2007 |
| * | K112095 | Acculif TL-Peek Ibf CageSummary page 5…es, including R Tree Innovations Epicage (K092901), SeaSpine Hollywood (K082310), Spinal Elements Lucent (K122967, K071724) and CoAlign Innovations AccuLIF TL-PEEK Cage (K112095 and K093669). Comparisons were designed to show the indications, intended use, design, and performance are equivalent between the… | 2011 |
| * | K093669 | Sec Ibf CageSummary page 5…g R Tree Innovations Epicage (K092901), SeaSpine Hollywood (K082310), Spinal Elements Lucent (K122967, K071724) and CoAlign Innovations AccuLIF TL-PEEK Cage (K112095 and K093669). Comparisons were designed to show the indications, intended use, design, and performance are equivalent between the Benvenue Lu… | 2010 |
What descends from it? (5)
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 30 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 53 ancestors have a recall of any class.
- Of its descendants, K162431 (Benvenue Medical, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K130254.
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. 2014, 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 Luna 360 Interbody Fusion System consists of the Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, These DDD patients may also have up to grade 1…
Read the full statement (125 words)
The Luna 360 Interbody Fusion System consists of the Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, These DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Luna 360 Interbody Fusion System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant, The Luna 360 Interbody Fusion System is to be used with supplemental fixation.
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/K142023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142023: Luna Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142023
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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