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 Aug 24, 2018 as substantially equivalent to K143158 (Xenco Medical, LLC, 2015) and 2 other predicates after a 193-day review. Its family tree reaches back 15 generations to 1984. 1 of the 114 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 24, 2018
- Review
- 193 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K841189 (1984). 113 ancestors in all. No later device cites it as a predicate yet. 1 of the 114 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- This deviceK180373 CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC · 2018
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 7 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 6 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 5 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 4 generations backK103169 AleuttianK2m, Inc. · 2011
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- This deviceK180373 CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC · 2018
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −7 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −6 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −5 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −4 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −3 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −2 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −1 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| 0 (this device) | K180373 | CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 16 | 1 |
| 2009 | 8 | 0 |
| 2010 | 2 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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.
1 device in this family has 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 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? (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 |
|---|---|---|---|
| * | K143158 | Xenco Medical Lumbar Interbody SystemSummary page 4…&RGH Primary Xenco Medical, K143158 Xenco Medical Lumbar Interbody System MAX Predicate… | 2015 |
| * | K150481 | Cascadia Interbody SystemSummary page 4…r Interbody System MAX Predicate LLC. $GGLWLRQDO3UHGLFDWHV Predicate K150481 Cascadia Interbody System K2M MAX… | 2015 |
| * | K152011 | Lucent Intervertebral Body Fusion DeviceSummary page 4…scadia Interbody System K2M MAX Spinal Elements, Predicate K152011 Lucent XP Ti-Bond® MAX… | 2016 |
| † | K081171 | Tritanium Acetabular Shell System | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 17 of the 113 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K143158.
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. 2018, 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 | — |
What is it indicated for?
CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have…
Read the full statement (165 words)
CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CancelleX device.
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/K180373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180373: CancelleX Porous Titanium Lumbar Interbody Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180373
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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