510(k) · Cleared

Cleared

Ellys and Aurys Vertebral Body Replacements

K033109510(k) TraditionalCleared Mar 23, 2004175-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

Scient'X · MQP Spinal Vertebral Body Replacement Device

Cleared on Mar 23, 2004 as substantially equivalent to K031757 (Signus Medical, LLC, 2003) and 1 other predicate after a 175-day review. Its family tree reaches back 5 generations to 1984. 1 of the 1,230 devices in its family, counting itself, has a Class I recall. 1,218 later devices descend from it.

Decided: Mar 23, 2004
Review: 175 days
Class: Class II
Product code: MQP
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K841189 (1984). 11 ancestors in all. 1,218 later devices descend from it, 3 citing it directly. 1 of the 1,230 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 5 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
4 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
3 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
2 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
1 generation backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
This deviceK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
Descendant · cites it directly · 1,214 of its ownK043479 MC+ Partial VBRLdr Spine USA · 2005
Descendant · 2 generations on · 903 of its ownK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
Descendant · 2 generations on · 902 of its ownK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
Descendant · 2 generations on · 901 of its ownK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
Descendant · 2 generations on · 864 of its ownK100042 Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010

Showing 5 of 1,218 descendants. See all descendants

Descendants cleared per year

2005high 106 (2017) · low 0 (2007)2026

Class I recalls in this family

K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 1,218 · See all

K043479MC+ Partial VBRLdr Spine USA · 2005 · cites it directly1,214descendants
K080728LDR Spine Roi-C ImplantLdr Spine USA · 2008 · 2 generations on903descendants
K083857LDR Spine Roi-C ImplantLdr Spine USA · 2009 · 2 generations on902descendants
K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009 · 2 generations on901descendants
K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010 · 2 generations on864descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K841189	Oec/Rezaian Spinal Fixator	Orthopedic Equipment Co., Inc.	1984	—
−4	K990148	Stackable Cage System	Depuy Motech Acromed	1999	—
−3	K003043	Surgical Titanium Mesh System	Depuyacromed	2001	—
−2	K022793	Tetris Spinal Implant	Signus Medical, LLC	2003	—
−1	K031757	Peek Tetris Spinal Implant	Signus Medical, LLC	2003	—
0 (this device)	K033109	Ellys and Aurys Vertebral Body Replacements	Scient'X	2004	—
+1	K043479	MC+ Partial VBR	Ldr Spine USA	2005	—
+2	K080728	LDR Spine Roi-C Implant	Ldr Spine USA	2008	—
+2	K083857	LDR Spine Roi-C Implant	Ldr Spine USA	2009	—
+2	K091088	LDR Spine Cervical Interbody Fusion System	Ldr Spine USA	2009	—
+2	K100042	Difusion Technologies Xiphos Interbody Fusion System	Difusion Technologies	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	4	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	2	0
2008	3	0
2009	4	0
2010	6	0
2011	18	0
2012	26	0
2013	34	0
2014	53	0
2015	64	0
2016	69	0
2017	106	0
2018	101	0
2019	95	0
2020	94	0
2021	86	1
2022	83	0
2023	106	0
2024	106	0
2025	82	0
2026	78	0

FIG. 1 — Lineage of K033109, 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.

1 device in this family has 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? (2)

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
*	K031757	Peek Tetris Spinal Implant Summary page 1 …ion 888.3060 Eqialn Device The Ellys and Aurys V7BR arc similar in design, material, use of'supplemnental lixatic'n and indications as the PEEK Tertris® (Signus Medical, K031757), and Verte-StackTM (Medtronic, K021791). Device Description The Elys components are kidney shaped and are used in pairs for ful…	Signus Medical, LLC	2003	—
*	K021791	Verte-Stack Spinal System Summary page 1 …Aurys V7BR arc similar in design, material, use of'supplemnental lixatic'n and indications as the PEEK Tertris® (Signus Medical, K031757), and Verte-StackTM (Medtronic, K021791). Device Description The Elys components are kidney shaped and are used in pairs for full corpectomy or individually when only a…	Medtronic Sofamor Danek	2002	—

Also cleared against K031757: 12 other devices →

What descends from it? (1,218)

See all 1,218

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

Number	Device	Applicant	Decided	Descendants
K043479	MC+ Partial VBR	Ldr Spine USA	2005	1,214
K050348	CO Vertebral Body Replacement	Scient'X	2005	2
K061752	Spinal Usa VBR System	Spinal USA	2006	0

Has anything in its family been recalled? (1 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.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
None of the 11 ancestors has a recall.
Of its descendants, K043479 (Ldr Spine USA, 2005) has gone furthest, with 1,214 descendants of its own.
12 other devices also cite its predicate K031757.

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?

Ellys and Aurys Vertebral Body Replacements are vertebral body replacements for use in the

lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body

due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR 06.2

Hemispherical Screws with Offset Clamps and 05.5 Rods must be utilized to enhance the

stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033109 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033109: Ellys and Aurys Vertebral Body Replacements.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033109

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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