510(k) · Cleared
ClearedX-Mesh Expandable Cage 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 May 1, 2008 as substantially equivalent to K030249 (Depuyacromed, 2003) and 1 other predicate after a 62-day review. Its family tree reaches back 5 generations to 1984. 1 of the 624 devices in its family, counting itself, has a Class I recall. 615 later devices descend from it.
- Decided
- May 1, 2008
- Review
- 62 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K841189 (1984). 8 ancestors in all. 615 later devices descend from it, 5 citing it directly. 1 of the 624 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 backK030249 Surgical Titanium Mesh SystemDepuyacromed · 2003
- This deviceK080568 X-Mesh Expandable Cage SystemDepuy Spine, Inc. · 2008
- Descendant · cites it directly · 591 of its ownK113348 Cougar SystemJohnson & Johnson · 2011
- Descendant · 2 generations on · 590 of its ownK140319 Coroent TI-C SystemNuvasive, Inc. · 2014
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
Showing 5 of 615 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 615 · See all- K113348Cougar SystemJohnson & Johnson · 2011 · cites it directly591descendants
- K140319Coroent TI-C SystemNuvasive, Inc. · 2014 · 2 generations on590descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 3 generations on402descendants
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 | K030249 | Surgical Titanium Mesh System | Depuyacromed | 2003 | — |
| 0 (this device) | K080568 | X-Mesh Expandable Cage System | Depuy Spine, Inc. | 2008 | — |
| +1 | K113348 | Cougar System | Johnson & Johnson | 2011 | — |
| +2 | K140319 | Coroent TI-C System | Nuvasive, Inc. | 2014 | — |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +3 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 17 | 0 |
| 2017 | 30 | 0 |
| 2018 | 34 | 0 |
| 2019 | 47 | 0 |
| 2020 | 67 | 0 |
| 2021 | 51 | 1 |
| 2022 | 63 | 0 |
| 2023 | 77 | 0 |
| 2024 | 85 | 0 |
| 2025 | 72 | 0 |
| 2026 | 59 | 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? (2)
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 |
|---|---|---|---|
| * | K030249 | Surgical Titanium Mesh SystemSummary page 1…FDA Panel Number: 87 Product Code(s): MQP Proprietary Name: X-MESHTm Expandable Cage System Predicate Devices: Surgical Titanium Mesh (K030249) Stackable Cage System (K013382) Device Description: The X-MESH Tm Expandable Cage System come… | 2003 |
| * | K013382 | Modification to: Stackable Cage SystemSummary page 1…Proprietary Name: X-MESHTm Expandable Cage System Predicate Devices: Surgical Titanium Mesh (K030249) Stackable Cage System (K013382) Device Description: The X-MESH Tm Expandable Cage System comes in three approach-specific shape… | 2001 |
What descends from it? (615)
See all 6155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113348 | Cougar System | 2011 | 591 |
| K133802 | Ais Modulift VBR System | 2014 | 48 |
| K142016 | CAPRI | 2014 | 12 |
| K091946 | Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XX | 2009 | 5 |
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System… | 2018 | 2 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K113348 (Johnson & Johnson, 2011) has gone furthest, with 591 descendants of its own.
- 1 other device also cites its predicate K030249.
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. 2008, this device’s year, is highlighted.
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 X-MESHTM Expandable Cage System is indicated for use in the thoracolumbar spine (i.e., TI to 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 X-MESHTM Expandable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The X-MESH TM Expandable Cage…
Read the full statement (162 words)
The X-MESHTM Expandable Cage System is indicated for use in the thoracolumbar spine (i.e., TI to 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 X-MESHTM Expandable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.
The X-MESH TM Expandable Cage 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 X-MESH TM Expandable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA TM SR, UNIVERSITY PLATE T M , M-2 ANTERIOR PLATE T M , ISOLA®, VSP®, MOSS®MIAMI, TiMX TM , MONARCHTM EXPEDIUM T M , VIPER TM , and PROFILE TM ).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080568: X-Mesh Expandable 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/K080568
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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