510(k) · Cleared

Cleared

Vertebral Body Replacement

K003155510(k) TraditionalCleared Jan 4, 200186-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

Osteotech, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Jan 4, 2001 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 2,092 devices in its family, counting itself, have a Class I recall. 2,091 later devices descend from it.

Decided: Jan 4, 2001
Review: 86 days
Class: Class II
Product code: MQP
Recalls: None
Predicates: 0

2,091 later devices descend from it, 7 citing it directly. 2 of the 2,092 devices in this family, counting this one, have a Class I recall.

This deviceK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
Descendant · cites it directly · 2,058 of its ownK012254 VBROsteotech, Inc. · 2001
Descendant · 2 generations on · 2,047 of its ownK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
Descendant · 3 generations on · 1,383 of its ownK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
Descendant · 3 generations on · 1,326 of its ownK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
Descendant · 3 generations on · 1,218 of its ownK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004

Showing 5 of 2,091 descendants. See all descendants

Descendants cleared per year

2001high 169 (2017) · low 1 (2001)2026

Class I recalls in this family

K051781 Graftcage TLX5 generations on · 2005
K211616 ExcelsiusHub8 generations on · 2021

Most influential descendants

Showing 5 of 2,091 · See all

K012254VBROsteotech, Inc. · 2001 · cites it directly2,058descendants
K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002 · 2 generations on2,047descendants
K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002 · 3 generations on1,383descendants
K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003 · 3 generations on1,326descendants
K033109Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004 · 3 generations on1,218descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003155	Vertebral Body Replacement	Osteotech, Inc.	2001	—
+1	K012254	VBR	Osteotech, Inc.	2001	—
+2	K021791	Verte-Stack Spinal System	Medtronic Sofamor Danek	2002	—
+3	K023570	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	2002	—
+3	K031780	Verte-Stack Spinal System	Medtronic Sofamor Danek	2003	—
+3	K033109	Ellys and Aurys Vertebral Body Replacements	Scient'X	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2003	4	0
2004	12	0
2005	20	1
2006	20	0
2007	14	0
2008	18	0
2009	20	0
2010	19	0
2011	48	0
2012	72	0
2013	92	0
2014	121	0
2015	118	0
2016	132	0
2017	169	0
2018	153	0
2019	145	0
2020	145	0
2021	127	1
2022	125	0
2023	160	0
2024	133	0
2025	116	0
2026	105	0

FIG. 1 — Lineage of K003155, 2001–2026Source: 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? (2,091)

See all 2,091

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

Number	Device	Applicant	Decided	Descendants
K012254	VBR	Osteotech, Inc.	2001	2,058
K050058	Theken Reveal VBR System	Theken Surgical,Llc	2005	727
K111294	Santorini Spinal System	K2m, Inc.	2012	18
K181921	Solidity Vertebral Body Replacement	Ulrich Medical USA	2018	2
K070181	Sintea Biotech DSC/Alf Spinal System, DSC.XX.T5.XX, Alf.XX.T5.XX	Sintea Biotech, Inc.	2007	1
K070786	X-Pod Adjustable Vertebral Body Replacement	Theken Spine, LLC	2007	0
K041798	Atalia Titanium Surgical Mesh	Us Spinal Technologies, LLC	2005	0

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 · 5 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K012254 (Osteotech, Inc., 2001) has gone furthest, with 2,058 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/K003155 · printed Nov 3, 2026

Cite this page

510(k) Report. “K003155: Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003155

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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