510(k) Report

510(k) · Cleared

Cleared

Bengal Stackable Cage System

K073649510(k) SpecialCleared Jan 25, 200830-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

Depuy Spine, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Jan 25, 2008 as substantially equivalent to K990148 (Depuy Motech Acromed, 1999) and 4 other predicates after a 30-day review. Its family tree reaches back 6 generations to 1984. 278 later devices descend from it.

Decided
Jan 25, 2008
Review
30 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K841189 (1984). 9 ancestors in all. 278 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2003: 1 other ancestor2001: 1 other ancestor2014: 1 descendant cleared2010: 2 descendants cleared2013: 5 descendants cleared2019: 20 descendants cleared2018: 10 descendants cleared2011: 3 descendants cleared2015: 6 descendants cleared2016: 6 descendants cleared2023: 35 descendants cleared2012: 1 descendant cleared2017: 7 descendants cleared2020: 19 descendants cleared2026: 40 descendants cleared2021: 14 descendants cleared2022: 30 descendants cleared2025: 38 descendants cleared2024: 41 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 13 descendants3 generations forward: 20 descendants4 generations forward: 22 descendants5 generations forward: 29 descendants6 generations forward: 43 descendants7 generations forward: 58 descendants8 generations forward: 43 descendants9 generations forward: 21 descendants10 generations forward: 10 descendants11 generations forward: 7 descendants12 generations forward: 5 descendants13 generations forward: 1 descendant K031635 · 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 · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 3 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  5. 2 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
  6. 1 generation backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
  7. This deviceK073649 Bengal Stackable Cage SystemDepuy Spine, Inc. · 2008
  8. Descendant · cites it directly · 204 of its ownK140759 Bengal System, Bengal Stackable System, Concorde Bullet Lumbar…Medos International SARL · 2014
  9. Descendant · 2 generations on · 201 of its ownK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
  10. Descendant · 3 generations on · 127 of its ownK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
  11. Descendant · 2 generations on · 111 of its ownK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
  12. Descendant · 4 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

Showing 5 of 278 descendants. See all descendants

Descendants cleared per year

2010: 22011: 32012: 12013: 52014: 12015: 62016: 62017: 72018: 102019: 202020: 192021: 142022: 302023: 352024: 412025: 382026: 40
2010high 41 (2024) · low 1 (2012)2026

Most influential descendants

Showing 5 of 278 · See all
  • K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL · 2014 · cites it directly204descendants
  • K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015 · 2 generations on201descendants
  • K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC · 2016 · 3 generations on127descendants
  • K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016 · 2 generations on111descendants
  • K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · 4 generations on109descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−5K990148Stackable Cage SystemDepuy Motech Acromed1999—
−4K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−3K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
−2K030833Depuy Acromed VBR SystemDepuyacromed2003—
−1K031635Depuy Acromed VBR SystemDepuyacromed2003—
0 (this device)K073649Bengal Stackable Cage SystemDepuy Spine, Inc.2008—
+1K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde…Medos International SARL2014—
+2K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201130
201210
201350
201410
201560
201660
201770
2018100
2019200
2020190
2021140
2022300
2023350
2024410
2025380
2026400
FIG. 1 — Lineage of K073649, 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.

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K990148Stackable Cage System
Summary page 1
…Spinal Intervertebral Body Fixation Orthosis Device PROPRIETARY NAME: Bengal Stackable Cage System PREDICATE DEVICES: Stackable Cage System (K990148, K001340) Surgical Titanium Mesh System (K003043, K020522)…
Depuy Motech Acromed1999—
*K001340Stackable Cage System
Summary page 1
…Spinal Intervertebral Body Fixation Orthosis Device PROPRIETARY NAME: Bengal Stackable Cage System PREDICATE DEVICES: Stackable Cage System (K990148, K001340) Surgical Titanium Mesh System (K003043, K020522)…
Depuyacromed2000—
*K003043Surgical Titanium Mesh System
Summary page 1
…ble Cage System PREDICATE DEVICES: Stackable Cage System (K990148, K001340) Surgical Titanium Mesh System (K003043, K020522) DePuy Acromed VBR System (K031635) INTENDED USE: The VBR Spinal System is indic…
Depuyacromed2001—
*K020522Modification to Surgical Titanium Mesh System
Summary page 1
…System PREDICATE DEVICES: Stackable Cage System (K990148, K001340) Surgical Titanium Mesh System (K003043, K020522) DePuy Acromed VBR System (K031635) INTENDED USE: The VBR Spinal System is indicated for…
Depuyacromed2002—
*K031635Depuy Acromed VBR System
Summary page 1
…148, K001340) Surgical Titanium Mesh System (K003043, K020522) DePuy Acromed VBR System (K031635) INTENDED USE: The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e.…
Depuyacromed2003—

Also cleared against K990148: 20 other devices →

What descends from it? (278)

See all 278

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

NumberDeviceApplicantDecidedDescendants
K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204
K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373
K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031
K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182
K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191
K190284Bengal Stackable Cage SystemMedos International SARL20190

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 24 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K140759 (Medos International SARL, 2014) has gone furthest, with 204 descendants of its own.
  • 20 other devices also cite its predicate K990148.

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. 2008, 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 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 System is also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal System is designed to restore the…

Read the full statement (149 words)

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 System is also indicated for treating fractures of the thoracic and lumbar spine.

The 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 VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA TM SR, UNIVERSITY PLATE TM, M-2 ANTERIOR PLATE TM, ISOLA®, VSP@, MOSS®MIAMI, TiMX TM, MONARCH T M, EXPEDIUMTM, VIPER TM, and PROFILE TM ).

Indications for use as stated in the FDA summary.

Also cleared against K990148

20 other devices cite the same predicate.

  • K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh…Medos International SARL · 2018
  • K092774Atlas Intervertebral Body CageSpinal Edge, LLC · 2010
  • K090566Pathway AvidCustom Spine, Inc. · 2009
  • K080281PathwayCustom Spine, Inc. · 2008
  • K061752Spinal Usa VBR SystemSpinal USA · 2006
  • K060916Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.Spinal Edge, LLC · 2006

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 MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K073649 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073649: Bengal Stackable 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/K073649

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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