510(k) · Cleared
ClearedConcorde Bullet Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson and Johnson · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 2, 2011 as substantially equivalent to K081917 (Depuy Spine, Inc., 2009) after a 96-day review. Its family tree reaches back 9 generations to 1984. 29 later devices descend from it.
- Decided
- Mar 2, 2011
- Review
- 96 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K841189 (1984). 17 ancestors in all. 29 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- This deviceK103488 Concorde Bullet Cage SystemJohnson and Johnson · 2011
- Descendant · cites it directly · 25 of its ownK120966 Depuy Pulse Lumbar Cage SystemMedos International SARL · 2012
- Descendant · 2 generations on · 15 of its ownK181397 DualXInnovasive, Inc. · 2018
- Descendant · 3 generations on · 5 of its ownK203038 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK173082 Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
- Descendant · 4 generations on · 4 of its ownK213355 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 5 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 4 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- This deviceK103488 Concorde Bullet Cage SystemJohnson and Johnson · 2011
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K120966Depuy Pulse Lumbar Cage SystemMedos International SARL · 2012 · cites it directly25descendants
- K181397DualXInnovasive, Inc. · 2018 · 2 generations on15descendants
- K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021 · 3 generations on5descendants
- K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018 · 2 generations on5descendants
- K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −5 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −4 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −3 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −1 | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | Depuy Spine, Inc. | 2009 | — |
| 0 (this device) | K103488 | Concorde Bullet Cage System | Johnson and Johnson | 2011 | — |
| +1 | K120966 | Depuy Pulse Lumbar Cage System | Medos International SARL | 2012 | — |
| +2 | K181397 | DualX | Innovasive, Inc. | 2018 | — |
| +3 | K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2021 | — |
| +2 | K173082 | Arco™-SA Lumbar Cage System | Neurostructures, Inc. | 2018 | — |
| +4 | K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 1…dy Fusion Device (888.3080) D. Predicate Device Name Trade name: DePuy Spine Concorde Bullet Spine System (K081917) DePuy Spine Bengal Spine System (K081917) E. Device Description The Concorde… | 2009 |
What descends from it? (29)
See all 294 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 27 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K120966 (Medos International SARL, 2012) has gone furthest, with 25 descendants of its own.
- 35 other devices also cite its predicate K081917.
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. 2011, 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 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…
Read the full statement (308 words)
The CONCORDE 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 either a PLIF or TLIF approach using autogenous bone. When used as interbody fusion devices these implants 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 may be used.
The CONCORDE and BENGAL System are indicated for use in the thoracolumbar spine (i.e., Ti-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 biomnechanical 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.
https://510kreport.com/device/K103488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103488: Concorde Bullet 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/K103488
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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