510(k) · Cleared
ClearedCougar LS 15 Lateral Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 18, 2012 as substantially equivalent to K082128 (Depuy Spine, 2008) and 1 other predicate after a 27-day review. Its family tree reaches back 11 generations to 1984. 205 later devices descend from it.
- Decided
- Oct 18, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K841189 (1984). 25 ancestors in all. 205 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- 2 generations backK101923 Concorde Curve SystemDepuy Spine · 2010
- 1 generation backK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
- This deviceK122896 Cougar LS 15 Lateral Cage SystemMedos International SARL · 2012
- Descendant · cites it directly · 204 of its ownK140759 Bengal System, Bengal Stackable System, Concorde Bullet Lumbar…Medos International SARL · 2014
- Descendant · 2 generations on · 201 of its ownK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- Descendant · 3 generations on · 127 of its ownK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
- Descendant · cites it directly · 111 of its ownK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
- Descendant · 4 generations on · 109 of its ownK171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2017
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 3 generations backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- 2 generations backK101923 Concorde Curve SystemDepuy Spine · 2010
- 1 generation backK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
- This deviceK122896 Cougar LS 15 Lateral Cage SystemMedos International SARL · 2012
Showing 5 of 205 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 205 · See all- K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL · 2014 · cites it directly204descendants
- K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015 · 2 generations on201descendants
- K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC · 2016 · 3 generations on127descendants
- K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016 · cites it directly111descendants
- K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · 4 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −7 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −5 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −3 | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | Depuy Spine, Inc. | 2009 | — |
| −2 | K101923 | Concorde Curve System | Depuy Spine | 2010 | — |
| −1 | K110454 | Cougar LS Lateral Cage System | Johnson & Johnson | 2011 | — |
| 0 (this device) | K122896 | Cougar LS 15 Lateral Cage System | Medos International SARL | 2012 | — |
| +1 | K140759 | Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde… | Medos International SARL | 2014 | — |
| +2 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| +3 | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | Synthes USA Products, LLC | 2016 | — |
| +1 | K162327 | COUGAR® LS Lateral Cage System and COUGAR® System | Medos International SARL | 2016 | — |
| +4 | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 9 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 25 | 0 |
| 2023 | 29 | 0 |
| 2024 | 36 | 0 |
| 2025 | 37 | 0 |
| 2026 | 34 | 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 |
|---|---|---|---|
| * | K082128 | Depuy Spine Lateral Cage SystemSummary page 1…ion device per 21 CFR §888.3080 0. Predicate Device Name Trade name: DePuy Spine Cougar' IS Lateral Cage System (K082128, K110454) E. Device Description The Cougar' IS Lateral System implants are manufactured fr… | 2008 |
| * | K110454 | Cougar LS Lateral Cage SystemSummary page 1…e per 21 CFR §888.3080 0. Predicate Device Name Trade name: DePuy Spine Cougar' IS Lateral Cage System (K082128, K110454) E. Device Description The Cougar' IS Lateral System implants are manufactured from Carbon… | 2011 |
What descends from it? (205)
See all 2052 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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K140759 (Medos International SARL, 2014) has gone furthest, with 204 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. 2012, 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 CougarO 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 (230 words)
The CougarO 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 th6 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 (ODD) at one or two contiguous levels from L2 to Si. These ODD patients may also have up to Grade 1 spondylolisthesis br retrolisthesis at the involved levels. ODD 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/K122896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122896: Cougar LS 15 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/K122896
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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