510(k) · Cleared
Recalled · Class II · 2019Cezanne II Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accel Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 9, 2013 as substantially equivalent to K090064 (Eminent Spine, 2009) and 4 other predicates after a 103-day review. Its family tree reaches back 11 generations to 1984. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 9, 2013
- Review
- 103 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 4
- Predicates
- 5
Its longest line of descent runs back 11 generations to K841189 (1984). 60 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK103034 Genesys Spine Interbody Fusion SystemGenesys Spine · 2010 · Recalled
- This deviceK131981 Cezanne II Interbody Fusion SystemAccel Spine · 2013
- Descendant · cites it directly · 3 of its ownK192863 MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020
- Descendant · 2 generations on · 1 of its ownK213641 MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022
- Descendant · cites it directly · 0 of its ownK231715 MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK220513 NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
- Descendant · cites it directly · 0 of its ownK212389 Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC · 2021
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK103034 Genesys Spine Interbody Fusion SystemGenesys Spine · 2010 · Recalled
- This deviceK131981 Cezanne II Interbody Fusion SystemAccel Spine · 2013
Most influential descendants
Showing 5 of 5 · See all- K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020 · cites it directly3descendants
- K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022 · 2 generations on1descendant
- K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024 · cites it directly0descendants
- K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023 · 2 generations on0descendants
- K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −5 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −4 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −3 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −1 | K103034 | Genesys Spine Interbody Fusion System | Genesys Spine | 2010 | 1 |
| 0 (this device) | K131981 | Cezanne II Interbody Fusion System | Accel Spine | 2013 | — |
| +1 | K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | Ctl Medical Corporation | 2020 | — |
| +2 | K213641 | MONDRIAN ALIF Cage with Supplementary Fixation Plate | Ctl Medical Corporation | 2022 | — |
| +1 | K231715 | MONDRIAN™ Anterior Lumbar Plate System | Ctl Medical Corporation | 2024 | — |
| +2 | K220513 | NITRO Interbody Fusion Cage System Family | Ctl Medical Corporation | 2023 | — |
| +1 | K212389 | Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF | Intelivation, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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? (5)
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 |
|---|---|---|---|
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 1…systems: - Eminent Spine: Eminent Spine Interbody Fusion System (K090064) - DePuy Acromed: Lumbar I/F Cage (P960025) - Genesys Spine… | 2009 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…Eminent Spine: Eminent Spine Interbody Fusion System (K090064) - DePuy Acromed: Lumbar I/F Cage (P960025) - Genesys Spine: Genesys Spine Interbody Fusion System (… | 1999 |
| * | K103034 | Genesys Spine Interbody Fusion SystemSummary page 1…DePuy Acromed: Lumbar I/F Cage (P960025) - Genesys Spine: Genesys Spine Interbody Fusion System (K103034) - Spine 360: Spine 360 Interbody Fusion System (K102322)… | 2010 |
| * | K102322 | Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Summary page 1…System (K103034) - Spine 360: Spine 360 Interbody Fusion System (K102322) - Lanx, Inc.: Lanx Fusion System - Lateral (K103666)… | 2011 |
| * | K103666 | Lanx LateralSummary page 1…pine 360: Spine 360 Interbody Fusion System (K102322) - Lanx, Inc.: Lanx Fusion System - Lateral (K103666) K(13 1981… | 2011 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2019 | Class II | Z-2504-2020 | Device Design | Reports received of the device fracturing during insertion. |
| Aug 21, 2019 | Class II | Z-2501-2020 | Device Design | Reports received of the device fracturing during insertion. |
| Aug 21, 2019 | Class II | Z-2502-2020 | Device Design | Reports received of the device fracturing during insertion. |
| Aug 21, 2019 | Class II | Z-2503-2020 | Device Design | Reports received of the device fracturing during insertion. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 60 ancestors have a recall of any class.
- Of its descendants, K192863 (Ctl Medical Corporation, 2020) has gone furthest, with 3 descendants of its own.
- 33 other devices also cite its predicate K090064.
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. 2013, 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?
The Cezanne 1IInterbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (ODD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131981: Cezanne II Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131981
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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