510(k) · Cleared

Cleared

Ebi Cas Spine Spacer System

K042268510(k) SpecialCleared Oct 27, 200465-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

Ebi, L.P. · MQP Spinal Vertebral Body Replacement Device

Cleared on Oct 27, 2004 as substantially equivalent to K040482 (Ebi, L.P., 2004) and 1 other predicate after a 65-day review. Its family tree reaches back 4 generations to 1984. 1 of the 1,630 devices in its family, counting itself, has a Class I recall. 1,620 later devices descend from it.

Decided: Oct 27, 2004
Review: 65 days
Class: Class II
Product code: MQP
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K841189 (1984). 9 ancestors in all. 1,620 later devices descend from it, 8 citing it directly. 1 of the 1,630 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
3 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
2 generations backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
1 generation backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
This deviceK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
Descendant · cites it directly · 1,571 of its ownK043206 Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005
Descendant · cites it directly · 1,440 of its ownK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
Descendant · 2 generations on · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
Descendant · 3 generations on · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
Descendant · cites it directly · 1,214 of its ownK043479 MC+ Partial VBRLdr Spine USA · 2005

Showing 5 of 1,620 descendants. See all descendants

Descendants cleared per year

2004high 139 (2023) · low 2 (2004)2026

Class I recalls in this family

K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 1,620 · See all

K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005 · cites it directly1,571descendants
K042930Spacevision Cage SystemSpine Vision, Inc. · 2004 · cites it directly1,440descendants
K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · 2 generations on1,406descendants
K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · 3 generations on1,405descendants
K043479MC+ Partial VBRLdr Spine USA · 2005 · cites it directly1,214descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K841189	Oec/Rezaian Spinal Fixator	Orthopedic Equipment Co., Inc.	1984	—
−3	K990148	Stackable Cage System	Depuy Motech Acromed	1999	—
−2	K020887	Ebi Ais Spine System	Ebi, L.P.	2002	—
−1	K040482	Ebi Esl Spine Spacer System	Ebi, L.P.	2004	—
0 (this device)	K042268	Ebi Cas Spine Spacer System	Ebi, L.P.	2004	—
+1	K043206	Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)	Pioneer Surgical Technology	2005	—
+1	K042930	Spacevision Cage System	Spine Vision, Inc.	2004	—
+2	K062759	Paramount VBR System	Innovative Spinal Technologies, Inc.	2007	—
+3	K072120	Paramount Intervertebral Body Fusion Device	Innovative Spinal Technologies, Inc.	2007	—
+1	K043479	MC+ Partial VBR	Ldr Spine USA	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	2	0
2002	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	6	0
2006	3	0
2007	8	0
2008	18	0
2009	11	0
2010	21	0
2011	43	0
2012	51	0
2013	62	0
2014	83	0
2015	83	0
2016	100	0
2017	124	0
2018	116	0
2019	117	0
2020	106	0
2021	105	1
2022	104	0
2023	139	0
2024	126	0
2025	101	0
2026	91	0

FIG. 1 — Lineage of K042268, 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

Get a 510(k) Report

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
*	K040482	Ebi Esl Spine Spacer System Summary page 1 …Spinal Vertebral Body Replacement Device/MQP 3. Predicate or legally marketed devices that are substantially equivalent: * FBI FSL Spine Spacer System (K040482) * EBI Ionic Spine Spacer System (K020887) 4. Description of the device: The GAS Spine Spacer System is design modifica…	Ebi, L.P.	2004	—
*	K020887	Ebi Ais Spine System Summary page 1 …QP 3. Predicate or legally marketed devices that are substantially equivalent: * FBI FSL Spine Spacer System (K040482) * EBI Ionic Spine Spacer System (K020887) 4. Description of the device: The GAS Spine Spacer System is design modification of the EBI ESL Spine Spacer System. The…	Ebi, L.P.	2002	—

Also cleared against K040482: 2 other devices →

What descends from it? (1,620)

See all 1,620

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

Number	Device	Applicant	Decided	Descendants
K043206	Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)	Pioneer Surgical Technology	2005	1,571
K042930	Spacevision Cage System	Spine Vision, Inc.	2004	1,440
K043479	MC+ Partial VBR	Ldr Spine USA	2005	1,214
K042714	Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4	Spine Next America Corporation	2004	838
K052384	Lanx VBR System	Lanx, LLC	2005	455
K091381	Ibex Spinal System	Ebi, L.P.	2009	181
K043349	Open Radiotransparent Intersomatic Implant (Roi)	Ldr Spine USA	2005	134
K071274	Gso GS1 Spacer	Gold Standard Orthopedics, LLC	2007	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 · 6 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 3 companies; a new generation was cleared every 2.7 years on median.
1 of the 9 ancestors has a recall of any class.
Of its descendants, K043206 (Pioneer Surgical Technology, 2005) has gone furthest, with 1,571 descendants of its own.
2 other devices also cite its predicate K040482.

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?

Read the full statement (139 words)

The EBI CAS Spine Spacer System is intended for use in the thoracolumbar spine (i.e., Ti- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI CAS Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI CAS Spine Spacer 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 of time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System, EBI SpineLink II Spinal System, or the EBI Array Spinal System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042268 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042268: Ebi Cas Spine Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042268

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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