510(k) Report

510(k) · Cleared

Recalled · 2005

Modification to Geo Structure

K040168510(k) SpecialCleared Apr 8, 200473-day reviewClass II21 CFR 888.3060Recalls 1

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 Apr 8, 2004 after a 73-day review. The FDA summary names no predicate by number. 239 later devices descend from it. It has been recalled once.

Decided
Apr 8, 2004
Review
73 days
Class
Class II
Product code
MQP
Recalls
1
Predicates
0

239 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2007: 2 descendants cleared2011: 3 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared2013: 4 descendants cleared2012: 1 descendant cleared2017: 9 descendants cleared2014: 2 descendants cleared2019: 15 descendants cleared2024: 32 descendants cleared2016: 4 descendants cleared2020: 18 descendants cleared2022: 21 descendants cleared2026: 32 descendants cleared2021: 16 descendants cleared2015: 2 descendants cleared2018: 8 descendants cleared2025: 34 descendants cleared2023: 32 descendants cleared200020052010201520202025
  1. This deviceK040168 Modification to Geo StructureInterpore Cross Intl. · 2004
  2. Descendant · cites it directly · 224 of its ownK050861 Peek CasInterpore Cross Intl. · 2005
  3. Descendant · 2 generations on · 181 of its ownK091381 Ibex Spinal SystemEbi, L.P. · 2009
  4. Descendant · 3 generations on · 177 of its ownK110650 Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC) · 2011
  5. Descendant · 2 generations on · 174 of its ownK112014 Zyston Straight Spacer SystemBiomet Spine · 2011
  6. Descendant · 3 generations on · 171 of its ownK122989 Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012

Showing 5 of 239 descendants. See all descendants

Descendants cleared per year

2005: 22007: 22008: 12009: 12011: 32012: 12013: 42014: 22015: 22016: 42017: 92018: 82019: 152020: 182021: 162022: 212023: 322024: 322025: 342026: 32
2005high 34 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 239 · See all
  • K050861Peek CasInterpore Cross Intl. · 2005 · cites it directly224descendants
  • K091381Ibex Spinal SystemEbi, L.P. · 2009 · 2 generations on181descendants
  • K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC) · 2011 · 3 generations on177descendants
  • K112014Zyston Straight Spacer SystemBiomet Spine · 2011 · 2 generations on174descendants
  • K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012 · 3 generations on171descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040168Modification to Geo StructureInterpore Cross Intl.2004—
+1K050861Peek CasInterpore Cross Intl.2005—
+2K091381Ibex Spinal SystemEbi, L.P.2009—
+3K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011—
+2K112014Zyston Straight Spacer SystemBiomet Spine2011—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200720
200810
200910
201130
201210
201340
201420
201520
201640
201790
201880
2019150
2020180
2021160
2022210
2023320
2024320
2025340
2026320
FIG. 1 — Lineage of K040168, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in MQP? 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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (239)

See all 239

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

NumberDeviceApplicantDecidedDescendants
K050861Peek CasInterpore Cross Intl.2005224
K052170Seaspine VBR SystemSeaspine, Inc.200513

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 14, 2005Not classifiedZ-0530-05OtherMislabeled.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K050861 (Interpore Cross Intl., 2005) has gone furthest, with 224 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

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
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

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace 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 GEO Structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure 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.

Indications for use as stated in the FDA summary.

More from Interpore Cross Intl.

39 FDA decisions under this applicant name. See the company

  • K050861Peek CasInterpore Cross Intl. · 2005
  • K031399Intergro DBMInterpore Cross Intl. · 20051 recall
  • K041407Titanium Mesh ImplantInterpore Cross Intl. · 2004
  • K043229Modification to Altius Oct SystemInterpore Cross Intl. · 2004
  • K042798C-Tek C-Trun Anterior Cervical Plate SystemInterpore Cross Intl. · 2004

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K040168 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040168: Modification to Geo Structure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040168

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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