510(k) Report

510(k) · Cleared

Cleared

Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems

K081917510(k) TraditionalCleared May 22, 2009323-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on May 22, 2009 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 8 other predicates after a 323-day review. Its family tree reaches back 8 generations to 1984. 1 of the 1,025 devices in its family, counting itself, has a Class I recall. 1,008 later devices descend from it.

Decided
May 22, 2009
Review
323 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
9

Its longest line of descent runs back 8 generations to K841189 (1984). 16 ancestors in all. 1,008 later devices descend from it, 36 citing it directly. 1 of the 1,025 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2003: 1 other ancestor2001: 2 other ancestors1999: 1 other ancestor1996: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor2014: 25 descendants cleared2015: 43 descendants cleared2010: 4 descendants cleared2011: 15 descendants cleared2017: 87 descendants cleared2012: 12 descendants cleared2013: 13 descendants cleared2016: 47 descendants cleared2018: 76 descendants cleared2024: 100 descendants cleared2023: 100 descendants cleared2020: 92 descendants cleared2021: 82 descendants cleared, 1 with a Class I recall12026: 75 descendants cleared2025: 81 descendants cleared2019: 80 descendants cleared2022: 76 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002×2: 2 generations cleared close together, K030833 (2003), K031635 (2003) K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 36 descendants2 generations forward: 94 descendants3 generations forward: 200 descendants4 generations forward: 262 descendants5 generations forward: 225 descendants, 1 with a Class I recall16 generations forward: 115 descendants7 generations forward: 52 descendants8 generations forward: 14 descendants9 generations forward: 8 descendants10 generations forward: 2 descendants K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K031635 · Depuy Acromed VBR System · Depuyacromed · 2003K030833 · Depuy Acromed VBR System · Depuyacromed · 2003K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−50+5+10
  1. Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 5 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  5. 4 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
  6. 3 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
  7. 2 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
  8. 1 generation backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
  9. This deviceK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
  10. Descendant · cites it directly · 609 of its ownK101923 Concorde Curve SystemDepuy Spine · 2010
  11. Descendant · cites it directly · 602 of its ownK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
  12. Descendant · cites it directly · 595 of its ownK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  13. Descendant · cites it directly · 591 of its ownK113348 Cougar SystemJohnson & Johnson · 2011
  14. Descendant · 2 generations on · 590 of its ownK140319 Coroent TI-C SystemNuvasive, Inc. · 2014

Showing 5 of 1,008 descendants. See all descendants

Descendants cleared per year

2010: 42011: 152012: 122013: 132014: 252015: 432016: 472017: 872018: 762019: 802020: 922021: 822022: 762023: 1002024: 1002025: 812026: 75
2010high 100 (2023) · low 4 (2010)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 1,008 · See all
  • K101923Concorde Curve SystemDepuy Spine · 2010 · cites it directly609descendants
  • K110454Cougar LS Lateral Cage SystemJohnson & Johnson · 2011 · cites it directly602descendants
  • K101302Aleutian Ibf SystemK2m, Inc. · 2010 · cites it directly595descendants
  • K113348Cougar SystemJohnson & Johnson · 2011 · cites it directly591descendants
  • K140319Coroent TI-C SystemNuvasive, Inc. · 2014 · 2 generations on590descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−7K990148Stackable Cage SystemDepuy Motech Acromed1999—
−6K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−5K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
−4K030833Depuy Acromed VBR SystemDepuyacromed2003—
−3K031635Depuy Acromed VBR SystemDepuyacromed2003—
−2K041722Modification to VBR Spinal SystemDepuy Spine, Inc.2004—
−1K052746Concorde VBR Spinal SystemDepuy Spine, Inc.2005—
0 (this device)K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.2009—
+1K101923Concorde Curve SystemDepuy Spine2010—
+1K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011—
+1K101302Aleutian Ibf SystemK2m, Inc.2010—
+1K113348Cougar SystemJohnson & Johnson2011—
+2K140319Coroent TI-C SystemNuvasive, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200010
200120
200210
200310
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201040
2011150
2012120
2013130
2014250
2015430
2016470
2017870
2018760
2019800
2020920
2021821
2022760
20231000
20241000
2025810
2026750
FIG. 1 — Lineage of K081917, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…COUGAR TM System DEVEX® System LEOPARD® System PREDICATE DEVICES: Lumbar I/F Cage System (P960025) DEVEX Mesh System (K023835) BAK Interbody Fusion System (P950002)…
Depuy Spine, Inc.1999—
*K023835Devex Mesh System
Summary page 1
…DEVEX® System LEOPARD® System PREDICATE DEVICES: Lumbar I/F Cage System (P960025) DEVEX Mesh System (K023835) BAK Interbody Fusion System (P950002) BAKICervical (BAKIC) Interbody Fusio…
Depuyacromed2003—
*P950002Bak Interbody Fusion System
Summary page 1
…REDICATE DEVICES: Lumbar I/F Cage System (P960025) DEVEX Mesh System (K023835) BAK Interbody Fusion System (P950002) BAKICervical (BAKIC) Interbody Fusion System (P980048) Cimplicity Spinal F…
Zimmer Spine, Inc.1996—
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 1
…DEVEX Mesh System (K023835) BAK Interbody Fusion System (P950002) BAKICervical (BAKIC) Interbody Fusion System (P980048) Cimplicity Spinal Fixation System (K073320) DePuy AcroMed VBR System (K031…
Sulzer Spine-Tech2001—
*K073320Cimplicity Spinal System
Summary page 1
…y Fusion System (P950002) BAKICervical (BAKIC) Interbody Fusion System (P980048) Cimplicity Spinal Fixation System (K073320) DePuy AcroMed VBR System (K031635), (K030833), (K041722)…
Spine Smith Partners L.P.2008—
*K031635Depuy Acromed VBR System
Summary page 1
…cal (BAKIC) Interbody Fusion System (P980048) Cimplicity Spinal Fixation System (K073320) DePuy AcroMed VBR System (K031635), (K030833), (K041722) CONCORDE VBR Spinal System (K052746)…
Depuyacromed2003—
*K030833Depuy Acromed VBR System
Summary page 1
…Interbody Fusion System (P980048) Cimplicity Spinal Fixation System (K073320) DePuy AcroMed VBR System (K031635), (K030833), (K041722) CONCORDE VBR Spinal System (K052746)…
Depuyacromed2003—
*K041722Modification to VBR Spinal System
Summary page 1
…Cimplicity Spinal Fixation System (K073320) DePuy AcroMed VBR System (K031635), (K030833), (K041722) CONCORDE VBR Spinal System (K052746) DEVEX Mesh System (K023835) DEVICE D…
Depuy Spine, Inc.2004—
*K052746Concorde VBR Spinal System
Summary page 1
…20) DePuy AcroMed VBR System (K031635), (K030833), (K041722) CONCORDE VBR Spinal System (K052746) DEVEX Mesh System (K023835) DEVICE DESCRIPTION: The BENGAL, CONCORDE, COUGAR, DEVEX, and…
Depuy Spine, Inc.2005—

Also cleared against P960025: 98 other devices →

What descends from it? (1,008)

See all 1,008

36 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101923Concorde Curve SystemDepuy Spine2010609
K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602
K101302Aleutian Ibf SystemK2m, Inc.2010595
K113348Cougar SystemJohnson & Johnson2011591
K110843Aleutian Spacer SystemK2m, Inc.2011589
K103169AleuttianK2m, Inc.2011572
K093093Small Plateau Spacer SystemLife Spine2010393
K102606Avs Anchor-C Cervical Cage SystemStryker Spine2011384
K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331
K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324

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 25 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
  • None of the 16 ancestors has a recall.
  • Of its descendants, K101923 (Depuy Spine, 2010) has gone furthest, with 609 descendants of its own.
  • 98 other devices also cite its predicate P960025.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications 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…

Read the full statement (439 words)

CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications

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.

BENGAL System Indications

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 may 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.

Indications for use as stated in the FDA summary.

Also cleared against P960025

98 other devices cite the same predicate.

  • K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with NanotechnologyNanovis, LLC · 2024
  • K191822Nano FortiCore, FortiCoreNanovis, LLC · 2019
  • K180230NEST Interbody SystemPaonan Biotech Co., Ltd. · 2019
  • K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd. · 2019
  • K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018

More from Depuy Spine, Inc.

86 FDA decisions under this applicant name. See the company

  • K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020
  • K142185Expedium Verse Spine SystemDepuy Spine, Inc. · 2014
  • K111136Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 20121 recall
  • K121020Viper SystemDepuy Spine, Inc. · 2012
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K081917 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081917

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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