510(k) · Cleared
ClearedCougar LS Lateral Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 13, 2011 as substantially equivalent to K081917 (Depuy Spine, Inc., 2009) and 4 other predicates after an 86-day review. Its family tree reaches back 10 generations to 1984. 1 of the 627 devices in its family, counting itself, has a Class I recall. 602 later devices descend from it.
- Decided
- May 13, 2011
- Review
- 86 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K841189 (1984). 24 ancestors in all. 602 later devices descend from it, 5 citing it directly. 1 of the 627 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 2 generations backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- 1 generation backK101923 Concorde Curve SystemDepuy Spine · 2010
- This deviceK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
- Descendant · cites it directly · 591 of its ownK113348 Cougar SystemJohnson & Johnson · 2011
- Descendant · 2 generations on · 590 of its ownK140319 Coroent TI-C SystemNuvasive, Inc. · 2014
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 6 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 5 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 4 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 2 generations backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- 1 generation backK101923 Concorde Curve SystemDepuy Spine · 2010
- This deviceK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
Showing 5 of 602 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 602 · See all- K113348Cougar SystemJohnson & Johnson · 2011 · cites it directly591descendants
- K140319Coroent TI-C SystemNuvasive, Inc. · 2014 · 2 generations on590descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 3 generations on402descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −6 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −5 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −4 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −2 | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | Depuy Spine, Inc. | 2009 | — |
| −1 | K101923 | Concorde Curve System | Depuy Spine | 2010 | — |
| 0 (this device) | K110454 | Cougar LS Lateral Cage System | Johnson & Johnson | 2011 | — |
| +1 | K113348 | Cougar System | Johnson & Johnson | 2011 | — |
| +2 | K140319 | Coroent TI-C System | Nuvasive, Inc. | 2014 | — |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +3 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 9 | 0 |
| 2016 | 17 | 0 |
| 2017 | 28 | 0 |
| 2018 | 31 | 0 |
| 2019 | 45 | 0 |
| 2020 | 65 | 0 |
| 2021 | 52 | 1 |
| 2022 | 61 | 0 |
| 2023 | 76 | 0 |
| 2024 | 83 | 0 |
| 2025 | 72 | 0 |
| 2026 | 58 | 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 |
|---|---|---|---|
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 1…n Device per 21 CFR §888.3080 0. Predicate Device Name Trade name: DePuy Spine Cougar® LS Lateral Cage System (K081917, K090899) Globus Medical Patriot Spacers (K072970) NuVasive CoRoent System (K071795)… | 2009 |
| * | K090899 | Depuy Spine Lateral SystemSummary page 1…per 21 CFR §888.3080 0. Predicate Device Name Trade name: DePuy Spine Cougar® LS Lateral Cage System (K081917, K090899) Globus Medical Patriot Spacers (K072970) NuVasive CoRoent System (K071795)… | 2009 |
| * | K072970 | Patriot SpacersSummary page 1…0. Predicate Device Name Trade name: DePuy Spine Cougar® LS Lateral Cage System (K081917, K090899) Globus Medical Patriot Spacers (K072970) NuVasive CoRoent System (K071795) OePuy Spine Concorde® Curve (K101923) === Page 2… | 2008 |
| * | K071795 | Nuvasive Coroent SystemSummary page 1…Puy Spine Cougar® LS Lateral Cage System (K081917, K090899) Globus Medical Patriot Spacers (K072970) NuVasive CoRoent System (K071795) OePuy Spine Concorde® Curve (K101923) E. Device Description The COUGAR® LS L… | 2007 |
| * | K101923 | Concorde Curve SystemSummary page 1…Globus Medical Patriot Spacers (K072970) NuVasive CoRoent System (K071795) OePuy Spine Concorde® Curve (K101923) E. Device Description The COUGAR® LS Lateral Cage System consists of the PEEK/carbon fiber… | 2010 |
What descends from it? (602)
See all 6025 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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 24 ancestors has a recall.
- Of its descendants, K113348 (Johnson & Johnson, 2011) has gone furthest, with 591 descendants of its own.
- 35 other devices also cite its predicate K081917.
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. 2011, 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 Cougar® LS 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 biomnechanical…
Read the full statement (229 words)
The Cougar® LS 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 biomnechanical integrity of the anterior, middle and posterior spinal column even in the 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 Cougaro LS 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 Si. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DOD isdefined 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/K110454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110454: Cougar LS 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/K110454
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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