510(k) · Cleared
ClearedDepuy Spine Lateral System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 19, 2009 as substantially equivalent to K082128 (Depuy Spine, 2008) and 4 other predicates after a 48-day review. Its family tree reaches back 8 generations to 1984. 1 of the 949 devices in its family, counting itself, has a Class I recall. 932 later devices descend from it.
- Decided
- May 19, 2009
- Review
- 48 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K841189 (1984). 16 ancestors in all. 932 later devices descend from it, 5 citing it directly. 1 of the 949 devices in this family, counting this one, has a Class I recall.
- 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 backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 4 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 3 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 2 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- This deviceK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- Descendant · cites it directly · 921 of its ownK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- Descendant · 2 generations on · 869 of its ownK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- Descendant · 3 generations on · 718 of its ownK113465 Acculif TL CageCoalign Innovations, Inc. · 2011
- Descendant · 3 generations on · 691 of its ownK113447 Rise SpacerGlobus Medical, Inc. · 2012
- Descendant · 4 generations on · 682 of its ownK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
Showing 5 of 932 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 932 · See all- K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009 · cites it directly921descendants
- K102293Caliber SpacerGlobus Medical, Inc. · 2011 · 2 generations on869descendants
- K113465Acculif TL CageCoalign Innovations, Inc. · 2011 · 3 generations on718descendants
- K113447Rise SpacerGlobus Medical, Inc. · 2012 · 3 generations on691descendants
- K121683Acculif TL CageCoalign Innovations, Inc. · 2012 · 4 generations on682descendants
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 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −4 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −3 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −2 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| 0 (this device) | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| +1 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| +2 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| +3 | K113465 | Acculif TL Cage | Coalign Innovations, Inc. | 2011 | — |
| +3 | K113447 | Rise Spacer | Globus Medical, Inc. | 2012 | — |
| +4 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K082128 | Depuy Spine Lateral Cage SystemSummary page 1…Intervertebral Body Fusion Device §888.3080 PROPRIETARY NAME: Lateral Cage System PREDICATE DEVICES: Lateral Cage System (K082128) Concorde VBR Spinal System (K041722, K052746) Stackable Cage System (K001340, K013… | 2008 |
| * | K041722 | Modification to VBR Spinal SystemSummary page 1…§888.3080 PROPRIETARY NAME: Lateral Cage System PREDICATE DEVICES: Lateral Cage System (K082128) Concorde VBR Spinal System (K041722, K052746) Stackable Cage System (K001340, K013382) DEVICE DESCRIPTION: The Lateral Cage System consist… | 2004 |
| * | K052746 | Concorde VBR Spinal SystemSummary page 1…§888.3080 PROPRIETARY NAME: Lateral Cage System PREDICATE DEVICES: Lateral Cage System (K082128) Concorde VBR Spinal System (K041722, K052746) Stackable Cage System (K001340, K013382) DEVICE DESCRIPTION: The Lateral Cage System consists of impl… | 2005 |
| * | K001340 | Stackable Cage SystemSummary page 1…PREDICATE DEVICES: Lateral Cage System (K082128) Concorde VBR Spinal System (K041722, K052746) Stackable Cage System (K001340, K013382) DEVICE DESCRIPTION: The Lateral Cage System consists of implants available in various height… | 2000 |
| * | K013382 | Modification to: Stackable Cage SystemSummary page 1…TE DEVICES: Lateral Cage System (K082128) Concorde VBR Spinal System (K041722, K052746) Stackable Cage System (K001340, K013382) DEVICE DESCRIPTION: The Lateral Cage System consists of implants available in various heights and lor… | 2001 |
What descends from it? (932)
See all 9325 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K093242 (Globus Medical, Inc., 2009) has gone furthest, with 921 descendants of its own.
- 4 other devices also cite its predicate K082128.
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. 2009, 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 use in the thoracolumbar spine (i.e., Ti to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of…
Read the full statement (222 words)
The Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., Ti to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column evefinithe absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation.
The Lateral Cage System is also 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. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental.internal fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090899: Depuy Spine Lateral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090899
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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