510(k) · Cleared

Cleared

Geo Structure

K010530510(k) TraditionalCleared Aug 3, 2001161-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

Interpore Cross Intl. · MQP Spinal Vertebral Body Replacement Device

Cleared on Aug 3, 2001 after a 161-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 1,765 devices in its family, counting itself, have a Class I recall. 1,764 later devices descend from it.

Decided: Aug 3, 2001
Review: 161 days
Class: Class II
Product code: MQP
Recalls: None
Predicates: 0

1,764 later devices descend from it, 10 citing it directly. 2 of the 1,765 devices in this family, counting this one, have a Class I recall.

This deviceK010530 Geo StructureInterpore Cross Intl. · 2001
Descendant · cites it directly · 1,622 of its ownK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
Descendant · 2 generations on · 1,621 of its ownK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
Descendant · 2 generations on · 1,620 of its ownK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
Descendant · 3 generations on · 1,571 of its ownK043206 Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005
Descendant · cites it directly · 1,559 of its ownK020048 Modification to Geo StructureInterpore Cross Intl. · 2002

Showing 5 of 1,764 descendants. See all descendants

Descendants cleared per year

2002high 140 (2023) · low 2 (2002)2026

Class I recalls in this family

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

Most influential descendants

Showing 5 of 1,764 · See all

K020887Ebi Ais Spine SystemEbi, L.P. · 2002 · cites it directly1,622descendants
K040482Ebi Esl Spine Spacer SystemEbi, L.P. · 2004 · 2 generations on1,621descendants
K042268Ebi Cas Spine Spacer SystemEbi, L.P. · 2004 · 2 generations on1,620descendants
K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005 · 3 generations on1,571descendants
K020048Modification to Geo StructureInterpore Cross Intl. · 2002 · cites it directly1,559descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010530	Geo Structure	Interpore Cross Intl.	2001	—
+1	K020887	Ebi Ais Spine System	Ebi, L.P.	2002	—
+2	K040482	Ebi Esl Spine Spacer System	Ebi, L.P.	2004	—
+2	K042268	Ebi Cas Spine Spacer System	Ebi, L.P.	2004	—
+3	K043206	Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)	Pioneer Surgical Technology	2005	—
+1	K020048	Modification to Geo Structure	Interpore Cross Intl.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	2	0
2004	6	0
2005	15	1
2006	9	0
2007	14	0
2008	28	0
2009	25	0
2010	33	0
2011	59	0
2012	61	0
2013	73	0
2014	95	0
2015	90	0
2016	103	0
2017	129	0
2018	120	0
2019	119	0
2020	108	0
2021	106	1
2022	109	0
2023	140	0
2024	126	0
2025	101	0
2026	91	0

FIG. 1 — Lineage of K010530, 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

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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? (1,764)

See all 1,764

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

Number	Device	Applicant	Decided	Descendants
K020887	Ebi Ais Spine System	Ebi, L.P.	2002	1,622
K020048	Modification to Geo Structure	Interpore Cross Intl.	2002	1,559
K031914	Spinal Concepts, Inc. Cadence and Fortitude	Spinal Concepts, Inc.	2003	1,530
K062083	Synfix -LR	Synthes Spine Co.Lp	2007	1,252
K031672	Spinal Concepts, Inc. Infix System	Spinal Concepts, Inc.	2003	862
K070082	XY Cor Spinal Implant for Minimal Invasive Spinal Surgery	Vertebration,Inc	2007	641
K062933	Synthes Oracle Spacer	Synthes Spine Co.Lp	2007	600
K052170	Seaspine VBR System	Seaspine, Inc.	2005	13
K173800	Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage	Camber Spine Technologies	2018	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, K020887 (Ebi, L.P., 2002) has gone furthest, with 1,622 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/K010530 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010530: Geo Structure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010530

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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