510(k) · Cleared

Cleared

Stackable Cage System

K990148510(k) TraditionalCleared Sep 3, 1999227-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

Depuy Motech Acromed · MQP Spinal Vertebral Body Replacement Device

Cleared on Sep 3, 1999 as substantially equivalent to K841189 (Orthopedic Equipment Co., Inc., 1984) after a 227-day review. Its family tree reaches back 1 generation to 1984. 2 of the 1,869 devices in its family, counting itself, have a Class I recall. 1,867 later devices descend from it.

Decided: Sep 3, 1999
Review: 227 days
Class: Class II
Product code: MQP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K841189 (1984). 1,867 later devices descend from it, 21 citing it directly. 2 of the 1,869 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
This deviceK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
Descendant · cites it directly · 1,819 of its ownK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
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 1,867 descendants. See all descendants

Descendants cleared per year

2001high 142 (2023) · low 2 (2001)2026

Class I recalls in this family

K051781 Graftcage TLX3 generations on · 2005
K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 1,867 · See all

K003043Surgical Titanium Mesh SystemDepuyacromed · 2001 · cites it directly1,819descendants
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
−1	K841189	Oec/Rezaian Spinal Fixator	Orthopedic Equipment Co., Inc.	1984	—
0 (this device)	K990148	Stackable Cage System	Depuy Motech Acromed	1999	—
+1	K003043	Surgical Titanium Mesh System	Depuyacromed	2001	—
+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	2	0
2003	7	0
2004	14	0
2005	23	1
2006	14	0
2007	15	0
2008	27	0
2009	21	0
2010	30	0
2011	70	0
2012	68	0
2013	84	0
2014	106	0
2015	98	0
2016	112	0
2017	136	0
2018	120	0
2019	124	0
2020	110	0
2021	107	1
2022	111	0
2023	142	0
2024	128	0
2025	102	0
2026	94	0

FIG. 1 — Lineage of K990148, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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? (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	Applicant	Decided	Recalls
*	K841189	Oec/Rezaian Spinal Fixator Summary page 2 …erformance of the device in patients with spine tumors. SUBSTANTIAL EQUIVALENCE.: The Stackable Cage System is substantially equivalent to the Rezaian Spinal Fixator (K841189). The claim of substantial equivalence is made solely for regulatory purposes and shall not be deemed to be an assertion of equiv…	Orthopedic Equipment Co., Inc.	1984	—

Also cleared against K841189: 8 other devices →

What descends from it? (1,867)

See all 1,867

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

Number	Device	Applicant	Decided	Descendants
K003043	Surgical Titanium Mesh System	Depuyacromed	2001	1,819
K022793	Tetris Spinal Implant	Signus Medical, LLC	2003	1,705
K020887	Ebi Ais Spine System	Ebi, L.P.	2002	1,622
K003836	Synthes Synex Spacer System	Synthes	2001	1,330
K032064	Theken Cpod/Lpod Vertebral Body Replacement System	Theken Surgical,Llc	2004	1,280
K023835	Devex Mesh System	Depuyacromed	2003	1,227
K030833	Depuy Acromed VBR System	Depuyacromed	2003	1,224
K031635	Depuy Acromed VBR System	Depuyacromed	2003	1,201
K041722	Modification to VBR Spinal System	Depuy Spine, Inc.	2004	1,150
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 · 3 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K003043 (Depuyacromed, 2001) has gone furthest, with 1,819 descendants of its own.
8 other devices also cite its predicate K841189.

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	—

What is it indicated for?

The Stackable Cage” System is indicated for use in the thoracolumbar spine (i.e., T1 to LS) 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 designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence…

Read the full statement (127 words)

The Stackable Cage” System is indicated for use in the thoracolumbar spine (i.e., T1 to

LS) 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 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 systems that may be used with the Stackable Cage System

include DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate,

M-2, ISOLA, VSP, Moss Miami, TiMX, and 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/K990148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990148: Stackable 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/K990148

Report an extraction error

Are you the manufacturer?

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