510(k) Report

510(k) · Cleared

Cleared

X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System

K173787510(k) TraditionalCleared Jun 11, 2018179-day reviewClass II21 CFR 888.3060

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

Medos International SARL · MQP Spinal Vertebral Body Replacement Device

Cleared on Jun 11, 2018 as substantially equivalent to K080568 (Depuy Spine, Inc., 2008) and 19 other predicates after a 179-day review. Its family tree reaches back 19 generations to 1984. 2 later devices descend from it.

Decided
Jun 11, 2018
Review
179 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
20

Its longest line of descent runs back 19 generations to K841189 (1984). 200 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 3 other ancestors2014: 7 other ancestors2012: 9 other ancestors2011: 13 other ancestors2010: 13 other ancestors2009: 18 other ancestors2008: 30 other ancestors2003: 13 other ancestors2002: 8 other ancestors2000: 1 other ancestor1999: 2 other ancestors1990: 1 other ancestor2013: 8 other ancestors2005: 10 other ancestors2004: 17 other ancestors2001: 10 other ancestors1996: 2 other ancestors2007: 11 other ancestors2006: 5 other ancestors2019: 1 descendant cleared2023: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K151773 · CONCORDE Bullet Lumbar Interbody System · Medos International SARL · 2015K162327 · COUGAR® LS Lateral Cage System and COUGAR® System · Medos International SARL · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 16 other ancestors2 generations back: 18 other ancestors3 generations back: 21 other ancestors4 generations back: 33 other ancestors5 generations back: 44 other ancestors6 generations back: 27 other ancestors7 generations back: 14 other ancestors8 generations back: 7 other ancestors9 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K162327 · COUGAR® LS Lateral Cage System and COUGAR® System · Medos International SARL · 2016K151773 · CONCORDE Bullet Lumbar Interbody System · Medos International SARL · 2015K143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−15−10−50
  1. Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 15 generations between
  3. 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  4. 2 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
  5. 1 generation backK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
  6. This deviceK173787 X-MESH® Expandable Cage System, OCELOT® Stackable Cage System…Medos International SARL · 2018
  7. Descendant · cites it directly · 1 of its ownK192214 CarboClear VBR SystemCarboFix Orthopedics, Ltd. · 2019
  8. Descendant · 2 generations on · 0 of its ownK222874 CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023
Show all 19 generations
  1. Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 2 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
  19. 1 generation backK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
  20. This deviceK173787 X-MESH® Expandable Cage System, OCELOT® Stackable Cage System…Medos International SARL · 2018

Most influential descendants

Showing 2 of 2 · See all
  • K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd. · 2019 · cites it directly1descendant
  • K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−18K990148Stackable Cage SystemDepuy Motech Acromed1999—
−17K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−16K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−15K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−14K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−13K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−12K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−11K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−10K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−9K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−8K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−7K121683Acculif TL CageCoalign Innovations, Inc.2012—
−6K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−5K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−4K141217Acculif TL and PL CageStryker Corporation20143
−3K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−2K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015—
−1K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016—
0 (this device)K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage…Medos International SARL2018—
+1K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.2019—
+2K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199620
199920
200010
2001100
200280
2003130
2004170
2005100
200650
2007110
2008300
2009180
2010130
2011130
201290
201380
201470
201530

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202310
FIG. 1 — Lineage of K173787, 1984–2023Source: 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.

Planning a device in MQP? 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 MQP device

  1. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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? (20)

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
*K080568X-Mesh Expandable Cage System
Summary page 12
…Surgical mesh D. Predicate Device Names Primary Predicate: X-MESH® Expandable Cage System (K080568) Additional Predicates: OCELOT® Stackable Cage System (K001340, K140759)…
Depuy Spine, Inc.2008—
*K001340Stackable Cage System
Summary page 12
…s Primary Predicate: X-MESH® Expandable Cage System (K080568) Additional Predicates: OCELOT® Stackable Cage System (K001340, K140759) Stackable Cage System (K990148)…
Depuyacromed2000—
*K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…
Summary page 12
…Primary Predicate: X-MESH® Expandable Cage System (K080568) Additional Predicates: OCELOT® Stackable Cage System (K001340, K140759) Stackable Cage System (K990148) Su…
Medos International SARL2014—
*K990148Stackable Cage System
Summary page 12
…8) Additional Predicates: OCELOT® Stackable Cage System (K001340, K140759) Stackable Cage System (K990148) Surgical Titanium Mesh System (K90…
Depuy Motech Acromed1999—
*K900138Motech Titanium Surgical Mesh
Summary page 12
…Stackable Cage System (K990148) Surgical Titanium Mesh System (K900138, K003043, K020522, K030249) BENGAL Stackable Cage System (K073649, K140759)…
Biedermann Motech GmbH1990—
*K003043Surgical Titanium Mesh System
Summary page 12
…Stackable Cage System (K990148) Surgical Titanium Mesh System (K900138, K003043, K020522, K030249) BENGAL Stackable Cage System (K073649, K140759)…
Depuyacromed2001—
*K020522Modification to Surgical Titanium Mesh System
Summary page 12
…able Cage System (K990148) Surgical Titanium Mesh System (K900138, K003043, K020522, K030249) BENGAL Stackable Cage System (K073649, K140759)…
Depuyacromed2002—
*K030249Surgical Titanium Mesh System
Summary page 12
…System (K990148) Surgical Titanium Mesh System (K900138, K003043, K020522, K030249) BENGAL Stackable Cage System (K073649, K140759)…
Depuyacromed2003—
*K073649Bengal Stackable Cage System
Summary page 12
…h System (K900138, K003043, K020522, K030249) BENGAL Stackable Cage System (K073649, K140759) BENGAL System (K081917, K103488)…
Depuy Spine, Inc.2008—
*K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems
Summary page 12
…22, K030249) BENGAL Stackable Cage System (K073649, K140759) BENGAL System (K081917, K103488) CONCORDE® System (K081917)…
Depuy Spine, Inc.2009—
*K103488Concorde Bullet Cage System
Summary page 12
…49) BENGAL Stackable Cage System (K073649, K140759) BENGAL System (K081917, K103488) CONCORDE® System (K081917) CONCORD…
Johnson and Johnson2011—
*K110694Concorde Bullet Spinal System
Summary page 12
…CONCORDE® System (K081917) CONCORDE® Inline Lumbar Interbody System (K110694, K140759) CONCORDE® Curve Lumbar Interbody System…
Johnson & Johnson2011—
*K101923Concorde Curve System
Summary page 12
…(K110694, K140759) CONCORDE® Curve Lumbar Interbody System (K101923) CONCORDE® Bullet Lumbar Interbody System…
Depuy Spine2010—
*K151352CONCORDE Bullet Spinal System
Summary page 12
…(K101923) CONCORDE® Bullet Lumbar Interbody System (K103488, K140759, K151352, K151773) COUGAR® System (K081917, K140759, K162327)…
Medos International SARL2015—
*K151773CONCORDE Bullet Lumbar Interbody System
Summary page 12
…01923) CONCORDE® Bullet Lumbar Interbody System (K103488, K140759, K151352, K151773) COUGAR® System (K081917, K140759, K162327)…
Medos International SARL2015—
*K162327COUGAR® LS Lateral Cage System and COUGAR® System
Summary page 12
…stem (K103488, K140759, K151352, K151773) COUGAR® System (K081917, K140759, K162327) COUGAR® LS Lateral Cage System (K140759, K162327)…
Medos International SARL2016—
*K031635Depuy Acromed VBR System
Summary page 12
…System (K140759, K162327) DEVEX® System (K081917, K140759) LEOPARD® System (K031635, K081917, K140759) DePuy PULSE Cervical Cage System (K120517)…
Depuyacromed2003—
*K120517Depuy Pulse Cervical Cage System
Summary page 12
…LEOPARD® System (K031635, K081917, K140759) DePuy PULSE Cervical Cage System (K120517) DePuy PULSE Lumbar Cage System (K120966)…
Medos International SARL2012—
*K120966Depuy Pulse Lumbar Cage System
Summary page 12
…DePuy PULSE Cervical Cage System (K120517) DePuy PULSE Lumbar Cage System (K120966) LUMBAR I/F CAGE® System (P960025)1 1 The devices subject to P960025 were…
Medos International SARL2012—
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 12
…(K120517) DePuy PULSE Lumbar Cage System (K120966) LUMBAR I/F CAGE® System (P960025)1 1 The devices subject to P960025 were reclassified from Class III (PMA) to Class II (510(k)) in September 2007 === Pag…
Depuy Spine, Inc.1999—

Also cleared against K080568: 4 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191

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 34 years and passes through 12 companies; a new generation was cleared every 11 months on median.
  • 23 of the 200 ancestors have a recall of any class.
  • Of its descendants, K192214 (CarboFix Orthopedics, Ltd., 2019) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K080568.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The Vertebral Body Replacement (VBR) Spinal Systems are 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…

Read the full statement (1,393 words)

The Vertebral Body Replacement (VBR) Spinal Systems are 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 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 products 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 products.

The CONCORDE Bullet and COUGAR 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 (L.2-S1). Additionally the CONCORDE Bullet and COUGAR Systems 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 either a PLIF or TLIF approach (CONCORDE Bullet) or an anterior approach (COUGAR) 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 CONCORDE Bullet and COUGAR 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 CONCORDE, CONCORDE Inline, CONCORDE Curve, 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 Inline) or TLIF (CONCORDE, CONCORDE Inline, CONCORDE Curve, DEVEX, LEOPARD) 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 Inline, CONCORDE Curve, 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 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 1 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 used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

The DePuy PULSE Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck 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. The DePuy PULSE Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. DePuy PULSE Cervical Cage System implants are intended to be used with supplemental internal fixation systems.

The DePuy PULSE Lumbar Cage System is 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 a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

The Lumbar I/F Cage System is indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360° fusion) and posterior pedicle screw fixation. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K173787: X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F 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/K173787

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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