510(k) · Cleared
ClearedModification to VBR Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Sep 23, 2004 as substantially equivalent to K030833 (Depuyacromed, 2003) and 4 other predicates after a 91-day review. Its family tree reaches back 6 generations to 1984. 1 of the 1,160 devices in its family, counting itself, has a Class I recall. 1,150 later devices descend from it.
- Decided
- Sep 23, 2004
- Review
- 91 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. 1,150 later devices descend from it, 3 citing it directly. 1 of the 1,160 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 3 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 2 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 1 generation backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- This deviceK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- Descendant · cites it directly · 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 · cites it directly · 932 of its ownK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- Descendant · 2 generations on · 921 of its ownK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- Descendant · 3 generations on · 869 of its ownK102293 Caliber SpacerGlobus Medical, Inc. · 2011
Showing 5 of 1,150 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 1,150 · See all- K052746Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005 · cites it directly1,149descendants
- K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009 · cites it directly1,008descendants
- K090899Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009 · cites it directly932descendants
- K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009 · 2 generations on921descendants
- K102293Caliber SpacerGlobus Medical, Inc. · 2011 · 3 generations on869descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −5 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −4 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −3 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −2 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −1 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| 0 (this device) | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| +1 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| +1 | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | Depuy Spine, Inc. | 2009 | — |
| +1 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| +2 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| +3 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 21 | 0 |
| 2012 | 21 | 0 |
| 2013 | 30 | 0 |
| 2014 | 41 | 0 |
| 2015 | 54 | 0 |
| 2016 | 69 | 0 |
| 2017 | 100 | 0 |
| 2018 | 87 | 0 |
| 2019 | 88 | 0 |
| 2020 | 95 | 0 |
| 2021 | 86 | 1 |
| 2022 | 84 | 0 |
| 2023 | 104 | 0 |
| 2024 | 100 | 0 |
| 2025 | 82 | 0 |
| 2026 | 77 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030833 | Depuy Acromed VBR SystemSummary page 1…Spinal Intervertebral Body Fixation Orthosis Device PROPRIETARY NAME: VBR Spinal System PREDICATE DEVICES: DePuy AcroMed VBR System (K030833) DePuy AcroMed VBR System (K031635) Stackable Cage System (K990148)… | 2003 |
| * | K031635 | Depuy Acromed VBR SystemSummary page 1…thosis Device PROPRIETARY NAME: VBR Spinal System PREDICATE DEVICES: DePuy AcroMed VBR System (K030833) DePuy AcroMed VBR System (K031635) Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522)… | 2003 |
| * | K990148 | Stackable Cage SystemSummary page 1…PREDICATE DEVICES: DePuy AcroMed VBR System (K030833) DePuy AcroMed VBR System (K031635) Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522) Devex Mesh System (K023835) DEVICE DE… | 1999 |
| * | K020522 | Modification to Surgical Titanium Mesh SystemSummary page 1…DePuy AcroMed VBR System (K031635) Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522) Devex Mesh System (K023835) DEVICE DESCRIPTION: Additional components in various sizes and footprints.… | 2002 |
| * | K023835 | Devex Mesh SystemSummary page 1…35) Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522) Devex Mesh System (K023835) DEVICE DESCRIPTION: Additional components in various sizes and footprints. The VBR Spinal System also… | 2003 |
What descends from it? (1,150)
See all 1,1503 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K052746 (Depuy Spine, Inc., 2005) has gone furthest, with 1,149 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 VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-5) 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…
Read the full statement (170 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 VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-5) 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 with the VBR Spinal System include DePuy Spine 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/K041722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041722: Modification to VBR Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041722
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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