510(k) · Cleared
Recalled · Class II · 2018XCage™ Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ouroboros Medical, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 13, 2016 as substantially equivalent to K133514 (Ouroboros Medical, 2014) and 1 other predicate after a 273-day review. Its family tree reaches back 14 generations to 1984. 14 later devices descend from it. It has been recalled once.
- Decided
- Oct 13, 2016
- Review
- 273 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 14 generations to K841189 (1984). 25 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK113527 Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012
- 2 generations backK123461 Staxx (R) IB SystemSpine Wave, Inc. · 2013 · Recalled
- 1 generation backK133514 Xcage Interbody Fusion SystemOuroboros Medical · 2014
- This deviceK160076 XCage™ Interbody Fusion SystemOuroboros Medical, Inc. · 2016
- Descendant · cites it directly · 12 of its ownK183184 FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK182114 FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019
- Descendant · 2 generations on · 5 of its ownK203038 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK213355 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK221894 Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 10 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 9 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 8 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 6 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 5 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 4 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 3 generations backK113527 Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012
- 2 generations backK123461 Staxx (R) IB SystemSpine Wave, Inc. · 2013 · Recalled
- 1 generation backK133514 Xcage Interbody Fusion SystemOuroboros Medical · 2014
- This deviceK160076 XCage™ Interbody Fusion SystemOuroboros Medical, Inc. · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019 · cites it directly12descendants
- K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019 · cites it directly6descendants
- K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021 · 2 generations on5descendants
- K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022 · 2 generations on4descendants
- K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −10 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −9 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −8 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −6 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −5 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −4 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −3 | K113527 | Opticage Interbody Fusion Device | Interventional Spine, Inc. | 2012 | — |
| −2 | K123461 | Staxx (R) IB System | Spine Wave, Inc. | 2013 | 1 |
| −1 | K133514 | Xcage Interbody Fusion System | Ouroboros Medical | 2014 | — |
| 0 (this device) | K160076 | XCage™ Interbody Fusion System | Ouroboros Medical, Inc. | 2016 | — |
| +1 | K183184 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2019 | — |
| +1 | K182114 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2019 | — |
| +2 | K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2021 | — |
| +2 | K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2022 | — |
| +3 | K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K133514 | Xcage Interbody Fusion SystemSummary page 4…XCage™ Interbody Fusion System Class IT per 21 CFR 888.3080 Intervertebral Fusion Device with Bone Graft, Lumbar MAX Primary: Ouroboros XCage Interbody Fusion System (K133514) Additional: Globus Medical, Inc. Caliber® (K102293) To achieve premarket clearance for the addition of the XCage Interbody spac… | 2014 |
| * | K102293 | Caliber SpacerSummary page 4…888.3080 Intervertebral Fusion Device with Bone Graft, Lumbar MAX Primary: Ouroboros XCage Interbody Fusion System (K133514) Additional: Globus Medical, Inc. Caliber® (K102293) To achieve premarket clearance for the addition of the XCage Interbody spacer line. Description of Device and Comparison: The… | 2011 |
What descends from it? (14)
See all 142 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 |
|---|---|---|---|---|
| Feb 27, 2018 | Class II | Z-0405-2019 | Under Investigation by firm | Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated information is provided to all accounts. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K183184 (Integrity Implants, Inc., 2019) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K133514.
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. 2016, 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 XCage™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment.…
Read the full statement (105 words)
The XCage™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). XCage™ System Spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
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/K160076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160076: XCage™ 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/K160076
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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