510(k) · Cleared

Cleared

VBR

K012254510(k) TraditionalCleared Oct 16, 200190-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 Oct 16, 2001 as substantially equivalent to K003155 (Osteotech, Inc., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. 2 of the 2,060 devices in its family, counting itself, have a Class I recall. 2,058 later devices descend from it.

Decided: Oct 16, 2001
Review: 90 days
Class: Class II
Product code: MQP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003155 (2001). 2,058 later devices descend from it, 18 citing it directly. 2 of the 2,060 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
This deviceK012254 VBROsteotech, Inc. · 2001
Descendant · cites it directly · 2,047 of its ownK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
Descendant · 2 generations on · 1,383 of its ownK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
Descendant · 2 generations on · 1,326 of its ownK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
Descendant · 2 generations on · 1,218 of its ownK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
Descendant · 3 generations on · 1,214 of its ownK043479 MC+ Partial VBRLdr Spine USA · 2005

Showing 5 of 2,058 descendants. See all descendants

Descendants cleared per year

2002high 166 (2017) · low 2 (2002)2026

Class I recalls in this family

K051781 Graftcage TLX4 generations on · 2005
K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 2,058 · See all

K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002 · cites it directly2,047descendants
K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002 · 2 generations on1,383descendants
K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003 · 2 generations on1,326descendants
K033109Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004 · 2 generations on1,218descendants
K043479MC+ Partial VBRLdr Spine USA · 2005 · 3 generations on1,214descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003155	Vertebral Body Replacement	Osteotech, Inc.	2001	—
0 (this device)	K012254	VBR	Osteotech, Inc.	2001	—
+1	K021791	Verte-Stack Spinal System	Medtronic Sofamor Danek	2002	—
+2	K023570	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	2002	—
+2	K031780	Verte-Stack Spinal System	Medtronic Sofamor Danek	2003	—
+2	K033109	Ellys and Aurys Vertebral Body Replacements	Scient'X	2004	—
+3	K043479	MC+ Partial VBR	Ldr Spine USA	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	4	0
2004	12	0
2005	18	1
2006	20	0
2007	10	0
2008	16	0
2009	19	0
2010	17	0
2011	44	0
2012	70	0
2013	89	0
2014	116	0
2015	117	0
2016	129	0
2017	166	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 K012254, 2001–2026Source: 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? (3)

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
*	K003155	Vertebral Body Replacement Summary page 2 …92 and ISO 5832/3 standards. The VBR™ is available in different sizes. Diameters of 20-28 mm with distraction lengths from 25 mm to 130 mm have previously been cleared (K003155). This current submission covers additional diameters ranging from 12 mm to 16 mm and distraction lengths from 10 mm to 65 mm, to…	Osteotech, Inc.	2001	—
*	—	OEC/Rezaian Spinal Fixator Named without a submission number			—
*	—	DePuy Acromed Stackable Named without a submission number			—

Also cleared against K003155: 6 other devices →

What descends from it? (2,058)

See all 2,058

18 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
K090841	Addplus	Ulrich GmbH & Co. KG	2009	215
K142205	NuVasive X-CORE (R) Expandable VBR System	Nuvasive, Inc.	2015	74
K060416	Obelisc Vertebral Body Replacement Device	Ulrich GmbH & Co. KG	2006	56
K110864	Biospine VBR System	Aesculap Implant Systems, LLC	2011	49
K133802	Ais Modulift VBR System	Aesculap Implant System, Inc.	2014	48
K181328	T2 STRATOSPHERE™ Expandable Corpectomy System	Medtronic Sofamor Danek USA, Inc.	2018	28
K151538	NuVasive PEEK Corpectomy Railed System	Nu Vasive, Incorporated	2015	13
K151167	NuVasive PEEK Corpectomy System	Nu Vasive, Incorporated	2015	13
K170055	CAPRI Corpectomy Cage System	K2m	2017	11

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 · 7 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, K021791 (Medtronic Sofamor Danek, 2002) has gone furthest, with 2,047 descendants of its own.
6 other devices also cite its predicate K003155.

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 VBR™ is a vertebral body replacement device intended for use in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture).

The VBR™ is intended to be used with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems.

The use of bone grafting material with the VBR™ is optional.

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/K012254 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012254: VBR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012254

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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

VBR