510(k) · Cleared
ClearedModification to Geo Structure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Cross Intl. · MQP Spinal Vertebral Body Replacement Device
Cleared on Feb 6, 2002 as substantially equivalent to K010530 (Interpore Cross Intl., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 2 of the 1,561 devices in its family, counting itself, have a Class I recall. 1,559 later devices descend from it.
- Decided
- Feb 6, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010530 (2001). 1,559 later devices descend from it, 3 citing it directly. 2 of the 1,561 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK010530 Geo StructureInterpore Cross Intl. · 2001
- This deviceK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
- Descendant · cites it directly · 1,530 of its ownK031914 Spinal Concepts, Inc. Cadence and FortitudeSpinal Concepts, Inc. · 2003
- Descendant · 2 generations on · 1,528 of its ownK033517 Spinal Concepts Inc. Cadence and TraxisSpinal Concepts, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- Descendant · 4 generations on · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- Descendant · 5 generations on · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
Showing 5 of 1,559 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,559 · See all- K031914Spinal Concepts, Inc. Cadence and FortitudeSpinal Concepts, Inc. · 2003 · cites it directly1,530descendants
- K033517Spinal Concepts Inc. Cadence and TraxisSpinal Concepts, Inc. · 2004 · 2 generations on1,528descendants
- K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · 3 generations on1,406descendants
- K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · 4 generations on1,405descendants
- K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · 5 generations on1,103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| 0 (this device) | K020048 | Modification to Geo Structure | Interpore Cross Intl. | 2002 | — |
| +1 | K031914 | Spinal Concepts, Inc. Cadence and Fortitude | Spinal Concepts, Inc. | 2003 | — |
| +2 | K033517 | Spinal Concepts Inc. Cadence and Traxis | Spinal Concepts, Inc. | 2004 | 1 |
| +3 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| +4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| +5 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 10 | 1 |
| 2006 | 7 | 0 |
| 2007 | 9 | 0 |
| 2008 | 15 | 0 |
| 2009 | 10 | 0 |
| 2010 | 17 | 0 |
| 2011 | 39 | 0 |
| 2012 | 42 | 0 |
| 2013 | 53 | 0 |
| 2014 | 79 | 0 |
| 2015 | 73 | 0 |
| 2016 | 93 | 0 |
| 2017 | 115 | 0 |
| 2018 | 111 | 0 |
| 2019 | 114 | 0 |
| 2020 | 107 | 0 |
| 2021 | 105 | 1 |
| 2022 | 106 | 0 |
| 2023 | 136 | 0 |
| 2024 | 125 | 0 |
| 2025 | 101 | 0 |
| 2026 | 88 | 0 |
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.
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K010530 | Geo StructureSummary page 1…/Usual Name: Vertebral Body Replacement Product Classification: Class II Proprietary Name: GEO™ Structure PREDICATE DEVICE The predicate device is the GEO™ Structure (K010530). INDICATIONS-FOR-USE The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased… | 2001 |
What descends from it? (1,559)
See all 1,5593 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020048: 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/K020048
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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