510(k) · Cleared

Cleared

Stackable Cage System

K001340510(k) TraditionalCleared Jul 26, 200090-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuyacromed · MQP Spinal Vertebral Body Replacement Device

Cleared on Jul 26, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 2,424 devices in its family, counting itself, have a Class I recall. 2,423 later devices descend from it.

Decided: Jul 26, 2000
Review: 90 days
Class: Class II
Product code: MQP
Recalls: None
Predicates: 0

2,423 later devices descend from it, 17 citing it directly. 2 of the 2,424 devices in this family, counting this one, have a Class I recall.

This deviceK001340 Stackable Cage SystemDepuyacromed · 2000
Descendant · cites it directly · 2,047 of its ownK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
Descendant · cites it directly · 1,705 of its ownK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
Descendant · 2 generations on · 1,702 of its ownK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
Descendant · cites it directly · 1,622 of its ownK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
Descendant · 2 generations on · 1,621 of its ownK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004

Showing 5 of 2,423 descendants. See all descendants

Descendants cleared per year

2001high 179 (2017) · low 2 (2001)2026

Class I recalls in this family

K051781 Graftcage TLX4 generations on · 2005
K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 2,423 · See all

K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002 · cites it directly2,047descendants
K022793Tetris Spinal ImplantSignus Medical, LLC · 2003 · cites it directly1,705descendants
K031757Peek Tetris Spinal ImplantSignus Medical, LLC · 2003 · 2 generations on1,702descendants
K020887Ebi Ais Spine SystemEbi, L.P. · 2002 · cites it directly1,622descendants
K040482Ebi Esl Spine Spacer SystemEbi, L.P. · 2004 · 2 generations on1,621descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001340	Stackable Cage System	Depuyacromed	2000	—
+1	K021791	Verte-Stack Spinal System	Medtronic Sofamor Danek	2002	—
+1	K022793	Tetris Spinal Implant	Signus Medical, LLC	2003	—
+2	K031757	Peek Tetris Spinal Implant	Signus Medical, LLC	2003	—
+1	K020887	Ebi Ais Spine System	Ebi, L.P.	2002	—
+2	K040482	Ebi Esl Spine Spacer System	Ebi, L.P.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2002	3	0
2003	11	0
2004	21	0
2005	34	1
2006	23	0
2007	21	0
2008	33	0
2009	30	0
2010	35	0
2011	81	0
2012	95	0
2013	120	0
2014	142	0
2015	135	0
2016	150	0
2017	179	0
2018	162	0
2019	152	0
2020	152	0
2021	137	1
2022	137	0
2023	179	0
2024	150	0
2025	128	0
2026	111	0

FIG. 1 — Lineage of K001340, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2,423)

See all 2,423

17 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021791	Verte-Stack Spinal System	Medtronic Sofamor Danek	2002	2,047
K022793	Tetris Spinal Implant	Signus Medical, LLC	2003	1,705
K020887	Ebi Ais Spine System	Ebi, L.P.	2002	1,622
K031914	Spinal Concepts, Inc. Cadence and Fortitude	Spinal Concepts, Inc.	2003	1,530
K003836	Synthes Synex Spacer System	Synthes	2001	1,330
K023835	Devex Mesh System	Depuyacromed	2003	1,227
K030833	Depuy Acromed VBR System	Depuyacromed	2003	1,224
K013382	Modification to: Stackable Cage System	Depuyacromed	2001	1,110
K090899	Depuy Spine Lateral System	Depuy Spine, Inc.	2009	932
K041617	Stalif TT	Surgicraft, Ltd.	2004	929

Has anything in its family been recalled? (2 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.

K051781Graftcage TLXOsteotech, Inc. · 2005 · 4 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K021791 (Medtronic Sofamor Danek, 2002) has gone furthest, with 2,047 descendants of its own.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007high 237 (2011) · low 47 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQP

1in 2022

2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007high 258 (2015) · low 61 (2007)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	—

https://510kreport.com/device/K001340 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001340: Stackable Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001340

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026