510(k) · Cleared
ClearedBengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar LS Lateral
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 Jun 13, 2014 as substantially equivalent to K073649 (Depuy Spine, Inc., 2008) and 9 other predicates after a 79-day review. Its family tree reaches back 12 generations to 1984. 204 later devices descend from it.
- Decided
- Jun 13, 2014
- Review
- 79 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 12 generations to K841189 (1984). 28 ancestors in all. 204 later devices descend from it, 6 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK101923 Concorde Curve SystemDepuy Spine · 2010
- 2 generations backK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
- 1 generation backK122896 Cougar LS 15 Lateral Cage SystemMedos International SARL · 2012
- This deviceK140759 Bengal System, Bengal Stackable System, Concorde Bullet Lumbar…Medos International SARL · 2014
- Descendant · cites it directly · 201 of its ownK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- Descendant · 2 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 · 3 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
- Descendant · 4 generations on · 108 of its ownK190959 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2019
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 8 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 4 generations backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- 3 generations backK101923 Concorde Curve SystemDepuy Spine · 2010
- 2 generations backK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
- 1 generation backK122896 Cougar LS 15 Lateral Cage SystemMedos International SARL · 2012
- This deviceK140759 Bengal System, Bengal Stackable System, Concorde Bullet Lumbar…Medos International SARL · 2014
Showing 5 of 204 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 204 · See all- K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015 · cites it directly201descendants
- K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC · 2016 · 2 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 · 3 generations on109descendants
- K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · 4 generations on108descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −8 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −4 | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | Depuy Spine, Inc. | 2009 | — |
| −3 | K101923 | Concorde Curve System | Depuy Spine | 2010 | — |
| −2 | K110454 | Cougar LS Lateral Cage System | Johnson & Johnson | 2011 | — |
| −1 | K122896 | Cougar LS 15 Lateral Cage System | Medos International SARL | 2012 | — |
| 0 (this device) | K140759 | Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde… | Medos International SARL | 2014 | — |
| +1 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| +2 | 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 | — |
| +3 | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +4 | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
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 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (10)
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 |
|---|---|---|---|
| * | K073649 | Bengal Stackable Cage SystemSummary page 4…as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation. BENGALO Stackable System: 510(k) submission K073649 cleared January 25, 2008. K(073649 The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., TI to… | 2008 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 3…the biomnechanical properties of human cortical bone, optimizing the likelihood of a sound arthrodesis. F. Intended Use BENGAL® System: This system was cleared in K081917 (VBR & IBF) on May 22, 2009. Intended Use listed respectively. K081917 CONCORDE, COUGAR, DEVEX, and LEOP… | 2009 |
| * | K052746 | Concorde VBR Spinal SystemSummary page 4…ATETIM , ISOLA®, VSPC,MOSSOMIAMI, TiMX TIM, MONARCH TM, EXPEDIUM TM,VIPER TM, and PROFILE TM). CONCORDEO Bullet Lumbar Interbody System: Original 510(k) submission K052746 (VBR) cleared October 21, 2005; subsequent K(081917 (VBR & IBF) cleared May 22, 2009. Intended Use listed respectively. === Page… | 2005 |
| * | K110694 | Concorde Bullet Spinal SystemSummary page 6…ended for use with OePuy Spine supplemental internal fixation. CONCORDEO Inline Lumbar Interbody System: 510(k) submission K(110694 cleared October 11, 2011. K110694 The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebr… | 2011 |
| * | K030833 | Depuy Acromed VBR SystemSummary page 6…R® System: Original 510(k) submission K(030833 (VBR) cleared April 4, 2003; subsequent K(081917 (VBR & IBF) cleared May 22, 2009. Intended Use listed respectively. K030833 The DePuy AcroMed VER System is indicated for use in the thoracolumbar spine (i.e., TI to L5) to replace a diseased ver… | 2003 |
| * | K082128 | Depuy Spine Lateral Cage SystemSummary page 8…LS Lateral Cage System: Original 510(k) submission K(082128 cleared November 14, 2008; subsequent K(110454 cleared May 13, 2011. Intended Use listed respectively. K082128 The Lateral Cage System is indicated for intervertebral body fusion with autogenous bone graft in patients with degener… | 2008 |
| * | K122896 | Cougar LS 15 Lateral Cage SystemSummary page 11…subject devices are identical to the predicate devices (K(073649, K(081917, K(052746, K(110694, K(030833, K(082128, K(122896, K(110454, K(023835, and K(001340) except that the subject devices will be terminally sterilized… | 2012 |
| * | K110454 | Cougar LS Lateral Cage SystemSummary page 8…ay be implanted via an open or a minimally invasive lateral approach. The Lateral Cage System is intended for use with DePuy Spine supplemental fixation. K110454 The COUGAR LS Lateral Cage System is indicated for use in,the thoracolumbar spine(i.e., Ti to [5) to replace a diseased… | 2011 |
| * | K023835 | Devex Mesh SystemSummary page 8…System: Original 510(k) submission K(023835 (VER) cleared January 29, 2003; subsequent K(081917 (VOR & ISP) cleared May 22, 2009. Intended Use listed respectively. K023835 I The Devex Mesh System is indicated for use in the thoracolumbar spine (TI-L5) to replace a diseased* vertebr… | 2003 |
| * | K001340 | Stackable Cage SystemSummary page 11…ertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation. OCELOT® Stackable Cage System: 510(k) submission K001340 cleared July 26, 2000. K001340 The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., Ti t… | 2000 |
What descends from it? (204)
See all 2046 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151773 | CONCORDE Bullet Lumbar Interbody System | 2015 | 201 |
| K162327 | COUGAR® LS Lateral Cage System and COUGAR® System | 2016 | 111 |
| K151352 | CONCORDE Bullet Spinal System | 2015 | 3 |
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System… | 2018 | 2 |
| K192214 | CarboClear VBR System | 2019 | 1 |
| K190284 | Bengal Stackable Cage System | 2019 | 0 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K151773 (Medos International SARL, 2015) has gone furthest, with 201 descendants of its own.
- 5 other devices also cite its predicate K073649.
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. 2014, 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 CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices 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…
Read the full statement (1,694 words)
The CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices 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 either a PLIF (CONCORDE), TLIF (CONCORDE, DEVEX, LEOPARD) or 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 CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are 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.
The BENGAL 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 level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation should be used.
The BENGAL 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. This 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 CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices 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 either a PLIF (CONCORDE, CONCORDE Bullet), TLIF (CONCORDE, CONCORDE Bullet, CONCORDE Curve, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are 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.
The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., 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 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 I 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.
The Lateral Cage System is 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 I 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. The Lateral Cage System is intended for use with DePuy Spine supplemental fixation.
The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., 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.
The VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine.
The VBR Spinal 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.
The VBR Spinal System is intended for use with supplemental internal fixation.
The Concorde VBR Spinal 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 Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.
The Concorde VBR Spinal 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.
The Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Concorde VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, Expedium, Viper, and Profile).
The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., 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.
The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The DePuy AcroMed VBR 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.
The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).
The Devex Mesh System is indicated for use in the thoracolumbar spine (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 Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.
The Devex Mesh 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.
The Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).
The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., 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.
The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.
The Stackable Cage 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.
The Stackable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Stackable Cage System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Profile).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140759: Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar LS Lateral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140759
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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