510(k) · Cleared
ClearedModification to: Stackable Cage 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 Nov 7, 2001 as substantially equivalent to K001340 (Depuyacromed, 2000) after a 26-day review. Its family tree reaches back 1 generation to 2000. 1 of the 1,112 devices in its family, counting itself, has a Class I recall. 1,110 later devices descend from it.
- Decided
- Nov 7, 2001
- Review
- 26 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001340 (2000). 1,110 later devices descend from it, 4 citing it directly. 1 of the 1,112 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK001340 Stackable Cage SystemDepuyacromed · 2000
- This deviceK013382 Modification to: Stackable Cage SystemDepuyacromed · 2001
- Descendant · cites it directly · 932 of its ownK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- Descendant · cites it directly · 929 of its ownK041617 Stalif TTSurgicraft, Ltd. · 2004
- Descendant · 2 generations on · 921 of its ownK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- Descendant · 2 generations on · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- Descendant · 3 generations on · 869 of its ownK102293 Caliber SpacerGlobus Medical, Inc. · 2011
Showing 5 of 1,110 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 1,110 · See all- K090899Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009 · cites it directly932descendants
- K041617Stalif TTSurgicraft, Ltd. · 2004 · cites it directly929descendants
- K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009 · 2 generations on921descendants
- K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · 2 generations on907descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K001340 | Stackable Cage System | Depuyacromed | 2000 | — |
| 0 (this device) | K013382 | Modification to: Stackable Cage System | Depuyacromed | 2001 | — |
| +1 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| +1 | K041617 | Stalif TT | Surgicraft, Ltd. | 2004 | — |
| +2 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| +2 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| +3 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 13 | 0 |
| 2012 | 16 | 0 |
| 2013 | 25 | 0 |
| 2014 | 41 | 0 |
| 2015 | 42 | 0 |
| 2016 | 66 | 0 |
| 2017 | 89 | 0 |
| 2018 | 82 | 0 |
| 2019 | 92 | 0 |
| 2020 | 98 | 0 |
| 2021 | 78 | 1 |
| 2022 | 84 | 0 |
| 2023 | 100 | 0 |
| 2024 | 96 | 0 |
| 2025 | 81 | 0 |
| 2026 | 75 | 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? (1)
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 |
|---|---|---|---|
| * | K001340 | Stackable Cage SystemSummary page 1…, MA 02780 Karen F. Jurczak October 10, 2001 Implant, Fixation Device Spinal Intervertebral Body Fixation Orthosis Device Stackable Cage System Stackable Cage System (K001340) The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body… | 2000 |
What descends from it? (1,110)
See all 1,1104 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?
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 Stackable Cage 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 the height of a collapsed vertebral body. The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Stackable Cage is designed to restore the…
Read the full statement (141 words)
The Stackable Cage 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 the height of a collapsed vertebral body.
The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.
The Stackable Cage 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 Stackable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation that may be used with the Stackable Cage System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, Profile).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013382: Modification to: Stackable Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013382
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026