510(k) · Cleared

Cleared

Vertebral Spacer

K011037510(k) TraditionalCleared Jul 1, 2002452-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

Synthes (Usa) · MQP Spinal Vertebral Body Replacement Device

Cleared on Jul 1, 2002 after a 452-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 1,375 devices in its family, counting itself, have a Class I recall. 1,374 later devices descend from it.

Decided: Jul 1, 2002
Review: 452 days
Class: Class II
Product code: MQP
Recalls: None
Predicates: 0

1,374 later devices descend from it, 11 citing it directly. 2 of the 1,375 devices in this family, counting this one, have a Class I recall.

This deviceK011037 Vertebral SpacerSynthes (Usa) · 2002
Descendant · cites it directly · 1,252 of its ownK062083 Synfix -LRSynthes Spine Co.Lp · 2007
Descendant · 2 generations on · 1,250 of its ownK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
Descendant · 3 generations on · 1,102 of its ownK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
Descendant · 4 generations on · 1,091 of its ownK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
Descendant · 3 generations on · 932 of its ownK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled

Showing 5 of 1,374 descendants. See all descendants

Descendants cleared per year

2004high 109 (2017) · low 2 (2004)2026

Class I recalls in this family

K051781 Graftcage TLXcites it directly · 2005
K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 1,374 · See all

K062083Synfix -LRSynthes Spine Co.Lp · 2007 · cites it directly1,252descendants
K072253Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · 2 generations on1,250descendants
K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008 · 3 generations on1,102descendants
K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008 · 4 generations on1,091descendants
K080083Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · 3 generations on932descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011037	Vertebral Spacer	Synthes (Usa)	2002	—
+1	K062083	Synfix -LR	Synthes Spine Co.Lp	2007	—
+2	K072253	Synfix-LR Spacer	Synthes Spine Co.Lp	2007	1
+3	K073470	Avs PL Peek Spacers, Models 48351XXX and 48353XXX	Stryker Spine	2008	—
+4	K080758	Avs PL Peek Spacers, Models 48351 and 48353	Stryker Corp.	2008	—
+3	K080083	Intrepid Spinal System	Medtronic Sofamor Danek	2008	8

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	6	1
2006	4	0
2007	7	0
2008	16	0
2009	15	0
2010	24	0
2011	36	0
2012	36	0
2013	42	0
2014	70	0
2015	68	0
2016	87	0
2017	109	0
2018	105	0
2019	101	0
2020	99	0
2021	89	1
2022	85	0
2023	105	0
2024	108	0
2025	83	0
2026	77	0

FIG. 1 — Lineage of K011037, 2002–2026Source: 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

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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? (1,374)

See all 1,374

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

Number	Device	Applicant	Decided	Descendants
K062083	Synfix -LR	Synthes Spine Co.Lp	2007	1,252
K042714	Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4	Spine Next America Corporation	2004	838
K051205	Stryker Spine Avs Asl Peek Spacer	Stryker Spine	2005	829
K043405	Nuvasive Coroent System	Nuvasive, Inc.	2005	712
K062933	Synthes Oracle Spacer	Synthes Spine Co.Lp	2007	600
K072981	Synthes Zero-P	Synthes Spine Co.Lp	2008	546
K070218	Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)	Vertiflex (Tm), Incorporated	2007	60
K053508	Synfix-LR	Synthes Spine Co.Lp	2006	39
K081383	Reliance VBS System	Reliance Medical Systems, LLC	2008	0
K051781	Graftcage TLX Class I	Osteotech, Inc.	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 · Cites it directly · ◆ 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?

Of its descendants, K062083 (Synthes Spine Co.Lp, 2007) has gone furthest, with 1,252 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/K011037 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011037: Vertebral Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011037

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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