510(k) · Cleared
ClearedDepuy Spine Lateral Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 14, 2008 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 1 other predicate after a 108-day review. Its family tree reaches back 2 generations to 2007. 1 of the 937 devices in its family, counting itself, has a Class I recall. 933 later devices descend from it.
- Decided
- Nov 14, 2008
- Review
- 108 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K071922 (2007). 3 ancestors in all, the oldest P960025 (1999). 933 later devices descend from it, 5 citing it directly. 1 of the 937 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK071922 Interplate Interbody Fusion Device, Models C, CGC, L and LGCRsb Spine, LLC · 2007
- 1 generation backK071795 Nuvasive Coroent SystemNuvasive, Inc. · 2007
- This deviceK082128 Depuy Spine Lateral Cage SystemDepuy Spine · 2008
- Descendant · cites it directly · 932 of its ownK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- Descendant · 2 generations on · 921 of its ownK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- Descendant · 3 generations on · 869 of its ownK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- Descendant · 4 generations on · 718 of its ownK113465 Acculif TL CageCoalign Innovations, Inc. · 2011
- Descendant · 4 generations on · 691 of its ownK113447 Rise SpacerGlobus Medical, Inc. · 2012
Showing 5 of 933 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 933 · See all- K090899Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009 · cites it directly932descendants
- K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009 · 2 generations on921descendants
- K102293Caliber SpacerGlobus Medical, Inc. · 2011 · 3 generations on869descendants
- K113465Acculif TL CageCoalign Innovations, Inc. · 2011 · 4 generations on718descendants
- K113447Rise SpacerGlobus Medical, Inc. · 2012 · 4 generations on691descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071922 | Interplate Interbody Fusion Device, Models C, CGC, L and LGC | Rsb Spine, LLC | 2007 | — |
| −1 | K071795 | Nuvasive Coroent System | Nuvasive, Inc. | 2007 | — |
| 0 (this device) | K082128 | Depuy Spine Lateral Cage System | Depuy Spine | 2008 | — |
| +1 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| +2 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| +3 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| +4 | K113465 | Acculif TL Cage | Coalign Innovations, Inc. | 2011 | — |
| +4 | K113447 | Rise Spacer | Globus Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 7 | 0 |
| 2012 | 10 | 0 |
| 2013 | 19 | 0 |
| 2014 | 19 | 0 |
| 2015 | 27 | 0 |
| 2016 | 48 | 0 |
| 2017 | 68 | 0 |
| 2018 | 66 | 0 |
| 2019 | 76 | 0 |
| 2020 | 90 | 0 |
| 2021 | 73 | 1 |
| 2022 | 81 | 0 |
| 2023 | 97 | 0 |
| 2024 | 93 | 0 |
| 2025 | 81 | 0 |
| 2026 | 74 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…Device with Bone Graft - 87MAX - 888.3080 - Class 11 PROPRIETARY NAME: Lateral Cage System PREDICATE DEVICES: LUMBAR I/F CAGE System (P960025) NuVasive CoRoent System (K071795) DEVICE DESCRIPTION: The Lateral Cage System consists of implant… | 1999 |
| * | K071795 | Nuvasive Coroent SystemSummary page 1…080 - Class 11 PROPRIETARY NAME: Lateral Cage System PREDICATE DEVICES: LUMBAR I/F CAGE System (P960025) NuVasive CoRoent System (K071795) DEVICE DESCRIPTION: The Lateral Cage System consists of implants available in various heights and… | 2007 |
What descends from it? (933)
See all 9335 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090899 | Depuy Spine Lateral System | 2009 | 932 |
| K122896 | Cougar LS 15 Lateral Cage System | 2012 | 205 |
| K140759 | Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar… | 2014 | 204 |
| K122989 | Biomet Lateral Spacer System | 2012 | 171 |
| K162327 | COUGAR® LS Lateral Cage System and COUGAR® System | 2016 | 111 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 1 year and passes through 3 companies; a new generation was cleared every 11 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K090899 (Depuy Spine, Inc., 2009) has gone furthest, with 932 descendants of its own.
- 98 other devices also cite its predicate P960025.
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. 2008, 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 Lateral Cage System is indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach.
The Lateral Cage System is intended for use with DePuy Spine supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082128: Depuy Spine Lateral Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082128
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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