510(k) · Cleared
ClearedCancelleX Porous Titanium Lumbar Interbody Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xenco Medical, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 18, 2019 after a 62-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Apr 18, 2019
- Review
- 62 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK190364 CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC · 2019
- Descendant · cites it directly · 4 of its ownK230219 Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC · 2023
- Descendant · 2 generations on · 2 of its ownK243074 Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253260 ORIO-3D Cage SystemSpineCraft · 2026
- Descendant · 3 generations on · 0 of its ownK252240 Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026
- Descendant · 3 generations on · 0 of its ownK253377 Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC · 2023 · cites it directly4descendants
- K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025 · 2 generations on2descendants
- K253260ORIO-3D Cage SystemSpineCraft · 2026 · 2 generations on0descendants
- K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026 · 3 generations on0descendants
- K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190364 | CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical, LLC | 2019 | — |
| +1 | K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | Eminent Spine, LLC | 2023 | — |
| +2 | K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025 | — |
| +2 | K253260 | ORIO-3D Cage System | SpineCraft | 2026 | — |
| +3 | K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026 | — |
| +3 | K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | 2023 | 4 |
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?
- Of its descendants, K230219 (Eminent Spine, LLC, 2023) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
https://510kreport.com/device/K190364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190364: CancelleX Porous Titanium Lumbar Interbody Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190364
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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