510(k) · Cleared
ClearedFortitude Vue Vertebral Body Replacement Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on May 19, 2005 as substantially equivalent to K031914 (Spinal Concepts, Inc., 2003) after a 29-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- May 19, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010530 (2001). 4 ancestors in all, the oldest K001340 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 2 generations backK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
- 1 generation backK031914 Spinal Concepts, Inc. Cadence and FortitudeSpinal Concepts, Inc. · 2003
- This deviceK051000 Fortitude Vue Vertebral Body Replacement DeviceSpinal Concepts, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −2 | K020048 | Modification to Geo Structure | Interpore Cross Intl. | 2002 | — |
| −1 | K031914 | Spinal Concepts, Inc. Cadence and Fortitude | Spinal Concepts, Inc. | 2003 | — |
| 0 (this device) | K051000 | Fortitude Vue Vertebral Body Replacement Device | Spinal Concepts, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 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.
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 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 |
|---|---|---|---|
| * | K031914 | Spinal Concepts, Inc. Cadence and FortitudeSummary page 1…CE: 21 CFR § 888.3060 PREDICATE DEVICE: FortitudeTm Titanium manufactured by Spinal Concepts Inc., K031914, cleared August 12, 2003. DEVICE DESCRIPTION: Fortitude Vue is a hollow device intended for use as… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K031914.
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?
Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). Fortitude Vue 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. Fortitude Vue is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051000: Fortitude Vue Vertebral Body Replacement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051000
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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