510(k) · Cleared
ClearedDevex Mesh 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 Jan 29, 2003 as substantially equivalent to K990148 (Depuy Motech Acromed, 1999) and 1 other predicate after a 72-day review. Its family tree reaches back 2 generations to 1984. 1 of the 1,231 devices in its family, counting itself, has a Class I recall. 1,227 later devices descend from it.
- Decided
- Jan 29, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K841189 (1984). 3 ancestors in all. 1,227 later devices descend from it, 7 citing it directly. 1 of the 1,231 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 1 generation backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- This deviceK023835 Devex Mesh SystemDepuyacromed · 2003
- Descendant · cites it directly · 1,224 of its ownK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- Descendant · cites it directly · 1,201 of its ownK031635 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
Showing 5 of 1,227 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 1,227 · See all- K030833Depuy Acromed VBR SystemDepuyacromed · 2003 · cites it directly1,224descendants
- K031635Depuy Acromed VBR SystemDepuyacromed · 2003 · cites it directly1,201descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −1 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| 0 (this device) | K023835 | Devex Mesh System | Depuyacromed | 2003 | — |
| +1 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 0 |
| 2011 | 26 | 0 |
| 2012 | 23 | 0 |
| 2013 | 37 | 0 |
| 2014 | 46 | 0 |
| 2015 | 60 | 0 |
| 2016 | 79 | 0 |
| 2017 | 106 | 0 |
| 2018 | 91 | 0 |
| 2019 | 97 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K003043 | FDA’s K003043 is Surgical Titanium Mesh System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| Kept off the family tree | K000522 | FDA’s K000522 is Screeners Barbiturate Test, Drugscreen Dip Barbiturate Test Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| * | K990148 | Stackable Cage SystemSummary page 1…inal intervertebral body fixation orthosis device PREDICATE DF‘di-?F c8Jrgica!Titmk- Mesh System (KO03-43, KWC522) Stackable Cage System (K990148, K001340) INTENDED USE: The Devex Mesh System is indicated for use in the thoracolumbar spin… | 1999 |
| * | K001340 | Stackable Cage SystemSummary page 1…rvertebral body fixation orthosis device PREDICATE DF‘di-?F c8Jrgica!Titmk- Mesh System (KO03-43, KWC522) Stackable Cage System (K990148, K001340) INTENDED USE: The Devex Mesh System is indicated for use in the thoracolumbar spine (Tl-L5)… | 2000 |
What descends from it? (1,227)
See all 1,2277 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030833 | Depuy Acromed VBR System | 2003 | 1,224 |
| K031635 | Depuy Acromed VBR System | 2003 | 1,201 |
| K041722 | Modification to VBR Spinal System | 2004 | 1,150 |
| K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | 2009 | 1,008 |
| K070082 | XY Cor Spinal Implant for Minimal Invasive Spinal Surgery | 2007 | 641 |
| K140759 | Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar… | 2014 | 204 |
| K151352 | CONCORDE Bullet Spinal System | 2015 | 3 |
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 · 6 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 15.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K030833 (Depuyacromed, 2003) has gone furthest, with 1,224 descendants of its own.
- 20 other devices also cite its predicate K990148.
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 Devex Mesh System is indicated for use in the thoracolumbar spine (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 the height of a collapsed vertebral body. The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine. The Devex Mesh System is designed to restore the biomechanical…
Read the full statement (141 words)
The Devex Mesh System is indicated for use in the thoracolumbar spine (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 the height of a collapsed vertebral body.
The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.
The Devex Mesh 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 Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Devex Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. 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/K023835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023835: Devex Mesh System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023835
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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