510(k) · Cleared
ClearedCOUGAR® LS Lateral Cage System and COUGAR® 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 Dec 12, 2016 as substantially equivalent to K140759 (Medos International SARL, 2014) and 8 other predicates after a 115-day review. Its family tree reaches back 18 generations to 1984. 111 later devices descend from it.
- Decided
- Dec 12, 2016
- Review
- 115 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 18 generations to K841189 (1984). 188 ancestors in all. 111 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- This deviceK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
- Descendant · cites it directly · 107 of its ownK170235 Lucent®Spinal Elements, Inc. · 2017
- Descendant · 2 generations on · 98 of its ownK181837 Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018
- Descendant · 3 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
- Descendant · 4 generations on · 72 of its ownK200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020
- Descendant · 5 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 7 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 5 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 4 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- This deviceK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
Showing 5 of 111 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 111 · See all- K170235Lucent®Spinal Elements, Inc. · 2017 · cites it directly107descendants
- K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018 · 2 generations on98descendants
- K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 3 generations on93descendants
- K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020 · 4 generations on72descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 5 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −7 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −5 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −4 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −3 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −1 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| 0 (this device) | K162327 | COUGAR® LS Lateral Cage System and COUGAR® System | Medos International SARL | 2016 | — |
| +1 | K170235 | Lucent® | Spinal Elements, Inc. | 2017 | — |
| +2 | K181837 | Spinal Elements Ti-Bond coated devices | Spinal Elements, Inc. | 2018 | — |
| +3 | K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | 2019 | — |
| +4 | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC | 2020 | — |
| +5 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 28 | 0 |
| 2009 | 15 | 0 |
| 2010 | 12 | 0 |
| 2011 | 12 | 0 |
| 2012 | 7 | 0 |
| 2013 | 8 | 0 |
| 2014 | 7 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 13 | 0 |
| 2023 | 19 | 0 |
| 2024 | 18 | 0 |
| 2025 | 24 | 0 |
| 2026 | 21 | 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? (9)
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 |
|---|---|---|---|
| * | K140759 | Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Summary page 6…Page 2 of 4 D. Predicate Device Name The subject devices are substantially equivalent to the primary predicate devices cleared under K140759, and the following additional predicate devices: COUGAR® (K081917, K113348), COUGAR® LS Lateral Cage System (K082128, K1104… | 2014 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 6…The subject devices are substantially equivalent to the primary predicate devices cleared under K140759, and the following additional predicate devices: COUGAR® (K081917, K113348), COUGAR® LS Lateral Cage System (K082128, K110454, K122896), Concorde Bullet Lumbar Interbody System (K1517… | 2009 |
| * | K113348 | Cougar SystemSummary page 6…evices are substantially equivalent to the primary predicate devices cleared under K140759, and the following additional predicate devices: COUGAR® (K081917, K113348), COUGAR® LS Lateral Cage System (K082128, K110454, K122896), Concorde Bullet Lumbar Interbody System (K151773), Medtronic… | 2011 |
| * | K082128 | Depuy Spine Lateral Cage SystemSummary page 6…primary predicate devices cleared under K140759, and the following additional predicate devices: COUGAR® (K081917, K113348), COUGAR® LS Lateral Cage System (K082128, K110454, K122896), Concorde Bullet Lumbar Interbody System (K151773), Medtronic CAPSTONE® Spinal System (K123027) an… | 2008 |
| * | K110454 | Cougar LS Lateral Cage SystemSummary page 6…predicate devices cleared under K140759, and the following additional predicate devices: COUGAR® (K081917, K113348), COUGAR® LS Lateral Cage System (K082128, K110454, K122896), Concorde Bullet Lumbar Interbody System (K151773), Medtronic CAPSTONE® Spinal System (K123027) and NuVasiv… | 2011 |
| * | K122896 | Cougar LS 15 Lateral Cage SystemSummary page 6…devices cleared under K140759, and the following additional predicate devices: COUGAR® (K081917, K113348), COUGAR® LS Lateral Cage System (K082128, K110454, K122896), Concorde Bullet Lumbar Interbody System (K151773), Medtronic CAPSTONE® Spinal System (K123027) and NuVasive CoRoent… | 2012 |
| * | K151773 | CONCORDE Bullet Lumbar Interbody SystemSummary page 6…dditional predicate devices: COUGAR® (K081917, K113348), COUGAR® LS Lateral Cage System (K082128, K110454, K122896), Concorde Bullet Lumbar Interbody System (K151773), Medtronic CAPSTONE® Spinal System (K123027) and NuVasive CoRoent® Lumbar System (K151472). E. Device Description… | 2015 |
| * | K123027 | Capstone (R) Spinal SystemSummary page 6…K113348), COUGAR® LS Lateral Cage System (K082128, K110454, K122896), Concorde Bullet Lumbar Interbody System (K151773), Medtronic CAPSTONE® Spinal System (K123027) and NuVasive CoRoent® Lumbar System (K151472). E. Device Description The COUGAR and COUGAR LS Lateral Cage Systems con… | 2013 |
| * | K151472 | NuVasive CoRoent Lumbar SystemSummary page 6…82128, K110454, K122896), Concorde Bullet Lumbar Interbody System (K151773), Medtronic CAPSTONE® Spinal System (K123027) and NuVasive CoRoent® Lumbar System (K151472). E. Device Description The COUGAR and COUGAR LS Lateral Cage Systems consists of PEEK/carbon fiber composite cag… | 2015 |
What descends from it? (111)
See all 1112 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 32 years and passes through 12 companies; a new generation was cleared every 11 months on median.
- 21 of the 188 ancestors have a recall of any class.
- Of its descendants, K170235 (Spinal Elements, Inc., 2017) has gone furthest, with 107 descendants of its own.
- 5 other devices also cite its predicate K140759.
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. 2016, 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?
COUGAR® LS Lateral Cage System: The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine (T1 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…
Read the full statement (529 words)
COUGAR® LS Lateral Cage System:
The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine (T1 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 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 COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion 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 from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels.
Additionally, the COUGAR LS Lateral Cage System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and may be implanted via an open or a minimally invasive lateral approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When use as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.
COUGAR® System:
The COUGAR System is indicated for use as 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). Additionally the COUGAR System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products.
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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are 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 these systems are intended for use with DePuy Spine supplemental internal fixation products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162327: COUGAR® LS Lateral Cage System and 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/K162327
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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