510(k) · Cleared
ClearedXcage Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ouroboros Medical · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 1, 2014 as substantially equivalent to K102293 (Globus Medical, Inc., 2011) and 2 other predicates after a 167-day review. Its family tree reaches back 13 generations to 1984. 15 later devices descend from it.
- Decided
- May 1, 2014
- Review
- 167 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K841189 (1984). 24 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 2 generations backK113527 Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012
- 1 generation backK123461 Staxx (R) IB SystemSpine Wave, Inc. · 2013 · Recalled
- This deviceK133514 Xcage Interbody Fusion SystemOuroboros Medical · 2014
- Descendant · cites it directly · 14 of its ownK160076 XCage™ Interbody Fusion SystemOuroboros Medical, Inc. · 2016 · Recalled
- 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
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 9 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 8 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 5 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 4 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 3 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 2 generations backK113527 Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012
- 1 generation backK123461 Staxx (R) IB SystemSpine Wave, Inc. · 2013 · Recalled
- This deviceK133514 Xcage Interbody Fusion SystemOuroboros Medical · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc. · 2016 · cites it directly14descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −9 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −8 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −5 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −4 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −3 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −2 | K113527 | Opticage Interbody Fusion Device | Interventional Spine, Inc. | 2012 | — |
| −1 | K123461 | Staxx (R) IB System | Spine Wave, Inc. | 2013 | 1 |
| 0 (this device) | K133514 | Xcage Interbody Fusion System | Ouroboros Medical | 2014 | — |
| +1 | K160076 | XCage™ Interbody Fusion System | Ouroboros Medical, Inc. | 2016 | 1 |
| +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 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K102293 | Caliber SpacerSummary page 1…The XCageTm Interbody Fusion System is substantially Information: equivalent to the Globus Medical, Inc. Caliber® (K102293), Globus Medical, Inc. Patriot® (K072970) and Spine Wave, Inc. StaXx® lB (KI 2346 1). All are Class… | 2011 |
| * | K072970 | Patriot SpacersSummary page 1…stem is substantially Information: equivalent to the Globus Medical, Inc. Caliber® (K102293), Globus Medical, Inc. Patriot® (K072970) and Spine Wave, Inc. StaXx® lB (KI 2346 1). All are Class 11 intervert… | 2008 |
| * | K123461 | Staxx (R) IB SystemSummary page 3…ates that it is substantially equivalent to the Globus Medical Caliber Spacer (K 10229'3), the Globus Medical Patriot® Spacer (K072970) and Spine Wave, Inc. StaXx® LB (K12346 1), all commercially available interbody ifusion devices. 46 DEIPARTMIENIOF FIEAIFiI & huMIVAN SERVICESI… | 2013 |
What descends from it? (15)
See all 153 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K160076 (Ouroboros Medical, Inc., 2016) has gone furthest, with 14 descendants of its own.
- 30 other devices also cite its predicate K102293.
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. 2014, 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 XCageTM 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 SI1, 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 XCageTM 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 SI1, 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 I spondylolisthesis or retrolisthesis at the involved level(s). XCageTrM system Spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133514: 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/K133514
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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