510(k) · Cleared
ClearedDepuy Acromed VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · MQP Spinal Vertebral Body Replacement Device
Cleared on Jun 23, 2003 as substantially equivalent to K030833 (Depuyacromed, 2003) and 3 other predicates after a 27-day review. Its family tree reaches back 5 generations to 1984. 1 of the 1,210 devices in its family, counting itself, has a Class I recall. 1,201 later devices descend from it.
- Decided
- Jun 23, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K841189 (1984). 8 ancestors in all. 1,201 later devices descend from it, 6 citing it directly. 1 of the 1,210 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 4 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 3 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 2 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 1 generation backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- This deviceK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- Descendant · cites it directly · 1,150 of its ownK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- Descendant · 2 generations on · 1,149 of its ownK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- Descendant · cites it directly · 1,008 of its ownK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- Descendant · 2 generations on · 932 of its ownK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- Descendant · 3 generations on · 921 of its ownK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
Showing 5 of 1,201 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 1,201 · See all- K041722Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004 · cites it directly1,150descendants
- K052746Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005 · 2 generations on1,149descendants
- K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009 · cites it directly1,008descendants
- K090899Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009 · 2 generations on932descendants
- K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009 · 3 generations on921descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −4 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −3 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −2 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −1 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| 0 (this device) | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| +1 | 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 | — |
| +2 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| +3 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 24 | 0 |
| 2012 | 22 | 0 |
| 2013 | 35 | 0 |
| 2014 | 41 | 0 |
| 2015 | 58 | 0 |
| 2016 | 73 | 0 |
| 2017 | 105 | 0 |
| 2018 | 91 | 0 |
| 2019 | 96 | 0 |
| 2020 | 98 | 0 |
| 2021 | 87 | 1 |
| 2022 | 86 | 0 |
| 2023 | 105 | 0 |
| 2024 | 101 | 0 |
| 2025 | 83 | 0 |
| 2026 | 80 | 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.
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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K030833 | Depuy Acromed VBR SystemSummary page 1…Spinal Intervertebral Body Fixation Orthosis Device PROPRIETARY NAME: DePuy AcroMed VBR System PREDICATE DEVICES: DePuy AcroMed VBR System (K030833) Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522)… | 2003 |
| * | K990148 | Stackable Cage SystemSummary page 1…hosis Device PROPRIETARY NAME: DePuy AcroMed VBR System PREDICATE DEVICES: DePuy AcroMed VBR System (K030833) Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522) Devex Mesh System (K023835) DEVICE DESC… | 1999 |
| * | K020522 | Modification to Surgical Titanium Mesh SystemSummary page 1…PREDICATE DEVICES: DePuy AcroMed VBR System (K030833) Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522) Devex Mesh System (K023835) DEVICE DESCRIPTION: Additional size components in various sizes and… | 2002 |
| * | K023835 | Devex Mesh SystemSummary page 1…30833) Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522) Devex Mesh System (K023835) DEVICE DESCRIPTION: Additional size components in various sizes and footprints. Th… | 2003 |
What descends from it? (1,201)
See all 1,2016 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041722 | Modification to VBR Spinal System | 2004 | 1,150 |
| K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | 2009 | 1,008 |
| K113348 | Cougar System | 2011 | 591 |
| K073649 | Bengal Stackable Cage System | 2008 | 278 |
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System… | 2018 | 2 |
| K053080 | Graftcage Acx | 2005 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K041722 (Depuy Spine, Inc., 2004) has gone furthest, with 1,150 descendants of its own.
- 6 other devices also cite its predicate K030833.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The indications for use for the modified devices described in this submission are the same as those for the DePuy AcroMed VBR System. The indications are as follows: The DePuy AcroMed VBR System is 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…
Read the full statement (175 words)
The indications for use for the modified devices described in this submission are the same as those for the DePuy AcroMed VBR System. The indications are as follows:
The DePuy AcroMed VBR System is 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.
The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The DePuy AcroMed VBR 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 DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the DePuy AcroMed VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, and Profile).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031635: Depuy Acromed VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031635
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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