510(k) · Cleared
ClearedCONCORDE Bullet Spinal System
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 Oct 8, 2015 as substantially equivalent to K140759 (Medos International SARL, 2014) and 2 other predicates after a 141-day review. Its family tree reaches back 13 generations to 1984. 3 later devices descend from it.
- Decided
- Oct 8, 2015
- Review
- 141 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K841189 (1984). 29 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
- 2 generations backK122896 Cougar LS 15 Lateral Cage SystemMedos International SARL · 2012
- 1 generation backK140759 Bengal System, Bengal Stackable System, Concorde Bullet Lumbar…Medos International SARL · 2014
- This deviceK151352 CONCORDE Bullet Spinal SystemMedos International SARL · 2015
- Descendant · cites it directly · 2 of its ownK173787 X-MESH® Expandable Cage System, OCELOT® Stackable Cage System…Medos International SARL · 2018
- Descendant · 2 generations on · 1 of its ownK192214 CarboClear VBR SystemCarboFix Orthopedics, Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK222874 CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 9 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 8 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 5 generations backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- 4 generations backK101923 Concorde Curve SystemDepuy Spine · 2010
- 3 generations backK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
- 2 generations backK122896 Cougar LS 15 Lateral Cage SystemMedos International SARL · 2012
- 1 generation backK140759 Bengal System, Bengal Stackable System, Concorde Bullet Lumbar…Medos International SARL · 2014
- This deviceK151352 CONCORDE Bullet Spinal SystemMedos International SARL · 2015
Most influential descendants
Showing 3 of 3 · See all- K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL · 2018 · cites it directly2descendants
- K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd. · 2019 · 2 generations on1descendant
- K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −9 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −8 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −5 | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | Depuy Spine, Inc. | 2009 | — |
| −4 | K101923 | Concorde Curve System | Depuy Spine | 2010 | — |
| −3 | K110454 | Cougar LS Lateral Cage System | Johnson & Johnson | 2011 | — |
| −2 | K122896 | Cougar LS 15 Lateral Cage System | Medos International SARL | 2012 | — |
| −1 | K140759 | Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde… | Medos International SARL | 2014 | — |
| 0 (this device) | K151352 | CONCORDE Bullet Spinal System | Medos International SARL | 2015 | — |
| +1 | K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage… | Medos International SARL | 2018 | — |
| +2 | K192214 | CarboClear VBR System | CarboFix Orthopedics, Ltd. | 2019 | — |
| +3 | K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics, Ltd. | 2023 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K140759 | Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Summary page 4…System, Concorde (Bullet and Inline) Lumbar Interbody System, Cougar System, Cougar LS Lateral Cage System, Leopard System (K140759) – Primary predicate MEDOS International, Sarl.,… | 2014 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 5…Page 2 of 3 DePuy Spine BENGAL, CONCORDE, COUGAR, DEVEX, and LEOPARD Systems (K081917) – Additional predicate DEVEX Mesh System (K023835) – Additional predicate E. Device Description… | 2009 |
| * | K023835 | Devex Mesh SystemSummary page 5…DePuy Spine BENGAL, CONCORDE, COUGAR, DEVEX, and LEOPARD Systems (K081917) – Additional predicate DEVEX Mesh System (K023835) – Additional predicate E. Device Description The CONCORDE Bullet Spinal System is a system of… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System… | 2018 | 2 |
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 31 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- None of the 29 ancestors has a recall.
- Of its descendants, K173787 (Medos International SARL, 2018) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K140759.
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. 2015, 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 Bullet Spinal 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…
Read the full statement (216 words)
The CONCORDE Bullet Spinal 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 products.
The CONCORDE Bullet 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 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 the use with DePuy Spine supplemental internal fixation products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151352: CONCORDE Bullet Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151352
Report an extraction error
Are you the manufacturer?
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