510(k) · Cleared
ClearedCougar 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 Dec 13, 2011 as substantially equivalent to K081917 (Depuy Spine, Inc., 2009) and 4 other predicates after a 29-day review. Its family tree reaches back 11 generations to 1984. 1 of the 619 devices in its family, counting itself, has a Class I recall. 591 later devices descend from it.
- Decided
- Dec 13, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K841189 (1984). 27 ancestors in all. 591 later devices descend from it, 3 citing it directly. 1 of the 619 devices in this family, counting this one, has a Class I recall.
- 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 deviceK113348 Cougar SystemJohnson & Johnson · 2011
- Descendant · cites it directly · 590 of its ownK140319 Coroent TI-C SystemNuvasive, Inc. · 2014
- Descendant · cites it directly · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 2 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
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 deviceK113348 Cougar SystemJohnson & Johnson · 2011
Showing 5 of 591 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 591 · See all- K140319Coroent TI-C SystemNuvasive, Inc. · 2014 · cites it directly590descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · cites it directly588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 2 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 2 generations on402descendants
- K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 3 generations on400descendants
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) | K113348 | Cougar System | Johnson & Johnson | 2011 | — |
| +1 | K140319 | Coroent TI-C System | Nuvasive, Inc. | 2014 | — |
| +1 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +2 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +2 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| +3 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
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 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 17 | 0 |
| 2017 | 27 | 0 |
| 2018 | 31 | 0 |
| 2019 | 43 | 0 |
| 2020 | 64 | 0 |
| 2021 | 51 | 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…pinal Intervertebral Fusion 21 CFR 888.3080 D. Predicate Device Name Trade name: DePuy Spine Cougar® System (K081917) DePuy Spine X-Mesh System (K080568) DePuy Spine.Leopard* System (K031635)… | 2009 |
| * | K080568 | X-Mesh Expandable Cage SystemSummary page 1…21 CFR 888.3080 D. Predicate Device Name Trade name: DePuy Spine Cougar® System (K081917) DePuy Spine X-Mesh System (K080568) DePuy Spine.Leopard* System (K031635) DePuy Spine Cougar IS Lateral Cage® System (K(… | 2008 |
| * | K031635 | Depuy Acromed VBR SystemSummary page 1…Trade name: DePuy Spine Cougar® System (K081917) DePuy Spine X-Mesh System (K080568) DePuy Spine.Leopard* System (K031635) DePuy Spine Cougar IS Lateral Cage® System (K(110454) DePuy Spine Concorde CurveO Sy… | 2003 |
| * | K110454 | Cougar LS Lateral Cage SystemSummary page 1…DePuy Spine X-Mesh System (K080568) DePuy Spine.Leopard* System (K031635) DePuy Spine Cougar IS Lateral Cage® System (K(110454) DePuy Spine Concorde CurveO System (K101923) DePuy Spine, Inc., a Johnson & Johnson Company… | 2011 |
| * | K101923 | Concorde Curve SystemSummary page 1…Puy Spine.Leopard* System (K031635) DePuy Spine Cougar IS Lateral Cage® System (K(110454) DePuy Spine Concorde CurveO System (K101923) DePuy Spine, Inc., a Johnson & Johnson Company Page 20… | 2010 |
What descends from it? (591)
See all 5913 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 27 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- None of the 27 ancestors has a recall.
- Of its descendants, K140319 (Nuvasive, Inc., 2014) has gone furthest, with 590 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 System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar…
Read the full statement (211 words)
The COUGAR System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation.
The COUGAR System is indicated for use in the thoracolumbar spine (i.e., T1-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. The COUGAR System is also indicated for treating fractures of the thoracic and lumbar spine. The COUGAR System is designed to restore the biomechanical 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, the COUGAR System is intended for use with DePuy Spine supplemental internal fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113348: Cougar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113348
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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