510(k) · Cleared
ClearedIntegrity Spine Lumbar Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrity Spine Lumbar Interbody Fusion System · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 10, 2015 as substantially equivalent to K100042 (Difusion Technologies, 2010) and 1 other predicate after a 127-day review. Its family tree reaches back 8 generations to 1984. 4 later devices descend from it.
- Decided
- Nov 10, 2015
- Review
- 127 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K841189 (1984). 28 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 2 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 1 generation backK100042 Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010
- This deviceK151819 Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System · 2015
- Descendant · cites it directly · 2 of its ownK171893 Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma…Bluestone Synergy · 2017
- Descendant · 2 generations on · 0 of its ownK210382 Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK203520 Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC · 2021
- Descendant · cites it directly · 0 of its ownK181030 Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy · 2017 · cites it directly2descendants
- K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC · 2021 · 2 generations on0descendants
- K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC · 2021 · 2 generations on0descendants
- K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −2 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −1 | K100042 | Difusion Technologies Xiphos Interbody Fusion System | Difusion Technologies | 2010 | — |
| 0 (this device) | K151819 | Integrity Spine Lumbar Interbody Fusion System | Integrity Spine Lumbar Interbody Fusion System | 2015 | — |
| +1 | K171893 | Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian)… | Bluestone Synergy | 2017 | — |
| +2 | K210382 | Blustone Synergy Diamond SA Cervical System | Blustone Synergy, LLC | 2021 | — |
| +2 | K203520 | Blustone Synergy Interbody Fusion System | Blustone Synergy, LLC | 2021 | — |
| +1 | K181030 | Rubicon Lumbar Interbody Fusion System | Rubicon Spine, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K100042 | Difusion Technologies Xiphos Interbody Fusion SystemSummary page 5…systems: Primary - DiFusion: Xiphos Interbody Fusion System (K100042) Secondary Additional Predicate… | 2010 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 5…Secondary Additional Predicate - DePuy Acromed: Lumbar I/F Cage (P960025) Reference Devices - Eminent Spine: Em… | 1999 |
| † | K090064 | Eminent Spine Interbody Fusion System | 2009 |
| † | P970015 | Inter Fix Threaded Fusion Device | 1999 |
| † | K082310 | Hollywood, Pacifica, Redondo, Ventura | 2008 |
| † | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | 2013 |
| † | K092193 | Spinal Usa Interbody Cages | 2009 |
What descends from it? (4)
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 31 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 28 ancestors have a recall of any class.
- Of its descendants, K171893 (Bluestone Synergy, 2017) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K100042.
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. 2015, 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 Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of…
Read the full statement (118 words)
The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151819: Integrity Spine Lumbar Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151819
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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