510(k) · Cleared
Recalled · 2004Spinal Concepts Inc. Cadence and Traxis
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 Feb 18, 2004 as substantially equivalent to K031914 (Spinal Concepts, Inc., 2003) after a 103-day review. Its family tree reaches back 3 generations to 2001. 2 of the 1,533 devices in its family, counting itself, have a Class I recall. 1,528 later devices descend from it. It has been recalled once.
- Decided
- Feb 18, 2004
- Review
- 103 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010530 (2001). 4 ancestors in all, the oldest K001340 (2000). 1,528 later devices descend from it, 6 citing it directly. 2 of the 1,533 devices in this family, counting this one, have a Class I recall.
- 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 deviceK033517 Spinal Concepts Inc. Cadence and TraxisSpinal Concepts, Inc. · 2004
- Descendant · cites it directly · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- Descendant · 2 generations on · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- Descendant · 3 generations on · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 4 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 3 generations on · 932 of its ownK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
Showing 5 of 1,528 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,528 · See all- K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · cites it directly1,406descendants
- K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · 2 generations on1,405descendants
- K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · 3 generations on1,103descendants
- K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 4 generations on1,008descendants
- K080083Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · 3 generations on932descendants
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) | K033517 | Spinal Concepts Inc. Cadence and Traxis | Spinal Concepts, Inc. | 2004 | — |
| +1 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| +2 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| +3 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +4 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +3 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
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 | 1 | 0 |
| 2005 | 9 | 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? (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…Product Code: MQP Predicate Device: CadenceTM (PEEK version) and TraXisTM are substantially equivalent to the titanium version of Cadence, cleared via K031914. Device Description: Cadence TM is a hollow device with texture on two opposing flat sides. The device is crafted from titanium… | 2003 |
What descends from it? (1,528)
See all 1,5286 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062759 | Paramount VBR System | 2007 | 1,406 |
| K040731 | Stryker Spine Vertebral Spacer | 2004 | 895 |
| K043405 | Nuvasive Coroent System | 2005 | 712 |
| K050449 | Quantum Vertebral Body Replacement | 2005 | 197 |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody… | 2015 | 19 |
| K052170 | Seaspine VBR System | 2005 | 13 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2004 | Not classified | Z-1343-04 | Other | Handle becomes loose after repeated use. |
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 3 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K062759 (Innovative Spinal Technologies, Inc., 2007) has gone furthest, with 1,406 descendants of its own.
- 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?
Cadence and TraXis 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 (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., 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/K033517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033517: Spinal Concepts Inc. Cadence and Traxis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033517
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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