510(k) · Cleared
ClearedSpinal Concepts, Inc. Cadence and Fortitude
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 Jul 12, 2003 as substantially equivalent to K010530 (Interpore Cross Intl., 2001) and 2 other predicates after a 22-day review. Its family tree reaches back 2 generations to 2001. 2 of the 1,534 devices in its family, counting itself, have a Class I recall. 1,530 later devices descend from it.
- Decided
- Jul 12, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K010530 (2001). 3 ancestors in all, the oldest K001340 (2000). 1,530 later devices descend from it, 2 citing it directly. 2 of the 1,534 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 1 generation backK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
- This deviceK031914 Spinal Concepts, Inc. Cadence and FortitudeSpinal Concepts, Inc. · 2003
- Descendant · cites it directly · 1,528 of its ownK033517 Spinal Concepts Inc. Cadence and TraxisSpinal Concepts, Inc. · 2004 · Recalled
- 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 · 4 generations on · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 5 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
Showing 5 of 1,530 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,530 · See all- K033517Spinal Concepts Inc. Cadence and TraxisSpinal Concepts, Inc. · 2004 · cites it directly1,528descendants
- K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · 2 generations on1,406descendants
- K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · 3 generations on1,405descendants
- K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · 4 generations on1,103descendants
- K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 5 generations on1,008descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −1 | K020048 | Modification to Geo Structure | Interpore Cross Intl. | 2002 | — |
| 0 (this device) | K031914 | Spinal Concepts, Inc. Cadence and Fortitude | Spinal Concepts, Inc. | 2003 | — |
| +1 | K033517 | Spinal Concepts Inc. Cadence and Traxis | Spinal Concepts, Inc. | 2004 | 1 |
| +2 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| +3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| +4 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +5 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 10 | 1 |
| 2006 | 7 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 7 | 0 |
| 2010 | 16 | 0 |
| 2011 | 36 | 0 |
| 2012 | 41 | 0 |
| 2013 | 49 | 0 |
| 2014 | 75 | 0 |
| 2015 | 72 | 0 |
| 2016 | 92 | 0 |
| 2017 | 114 | 0 |
| 2018 | 111 | 0 |
| 2019 | 114 | 0 |
| 2020 | 105 | 0 |
| 2021 | 104 | 1 |
| 2022 | 103 | 0 |
| 2023 | 135 | 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? (3)
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 Structure | 2001 |
| * | K020048 | Modification to Geo StructureSummary page 1…rpore Cross GEOTM Structure, which was cleared as an oval shaped configuration on August 3,2001 (KO10530) and as a rectangular shaped configuration on February 6 , 2002 (K020048), and to the DePuy AcroMed Stackable CageTMSystem cleared on July 26,2000 (KOO1340). Device Description: CadenceTMis a hollow de… | 2002 |
| * | K001340 | Stackable Cage System | 2000 |
What descends from it? (1,530)
See all 1,5302 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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K033517 (Spinal Concepts, Inc., 2004) has gone furthest, with 1,528 descendants of its own.
- 9 other devices also cite its predicate K010530.
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?
Cadence and Fortitude are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (Le., partial or total vertebrectomy procedures) due to tumor or trauma (Le., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031914: Spinal Concepts, Inc. Cadence and Fortitude.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031914
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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