510(k) · Cleared
ClearedInterbody Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aurora Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 31, 2014 as substantially equivalent to K130573 (Tyber Medical, LLC, 2013) after a 38-day review. Its family tree reaches back 12 generations to 2001. 227 later devices descend from it.
- Decided
- Jan 31, 2014
- Review
- 38 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K003155 (2001). 61 ancestors in all, the oldest K841189 (1984). 227 later devices descend from it, 7 citing it directly.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 1 generation backK130573 Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013
- This deviceK133967 Interbody Cage SystemAurora Spine · 2014
- Descendant · cites it directly · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
- Descendant · 2 generations on · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
- Descendant · 2 generations on · 109 of its ownK170157 INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 94 of its ownK173722 PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc. · 2018
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 6 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 5 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 4 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 1 generation backK130573 Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013
- This deviceK133967 Interbody Cage SystemAurora Spine · 2014
Showing 5 of 227 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 227 · See all- K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · cites it directly210descendants
- K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016 · 2 generations on117descendants
- K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017 · 2 generations on109descendants
- K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · 2 generations on97descendants
- K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc. · 2018 · 2 generations on94descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −6 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −2 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −1 | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | Tyber Medical, LLC | 2013 | — |
| 0 (this device) | K133967 | Interbody Cage System | Aurora Spine | 2014 | — |
| +1 | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… | Globus Medical, Inc. | 2016 | — |
| +2 | K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | Globus Medical, Inc. | 2016 | — |
| +2 | K170157 | INDEPENDENCE® Spacers | Globus Medical, Inc. | 2017 | — |
| +2 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
| +2 | K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | Globus Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 8 | 0 |
| 2020 | 17 | 0 |
| 2021 | 20 | 0 |
| 2022 | 27 | 0 |
| 2023 | 36 | 0 |
| 2024 | 40 | 0 |
| 2025 | 38 | 0 |
| 2026 | 26 | 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? (1)
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 |
|---|---|---|---|
| * | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifSummary page 2…ly equivalent to previously cleared device and has the same indications for use, design, function, and materials used. This device is the Tyber Medical Interbody System (K130573). Performance Standards: Non-clinical mechanical testing was performed consisting of Static and Dynamic Compression, Torsion, Co… | 2013 |
What descends from it? (227)
See all 2277 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers… | 2016 | 210 |
| K172064 | Ti-Diagon Oblique TLIF | 2017 | 27 |
| K173082 | Arco™-SA Lumbar Cage System | 2018 | 5 |
| K171657 | ShurFit 2C Lumbar Interbody Fusion System | 2017 | 4 |
| K221535 | Align Lumbar Interbody Fusion System | 2022 | 3 |
| K230639 | Align Cervical Interbody Fusion System | 2023 | 2 |
| K223043 | The Integrity Spine Core System | 2023 | 0 |
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 13 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 7 of the 61 ancestors have a recall of any class.
- Of its descendants, K143578 (Globus Medical, Inc., 2016) has gone furthest, with 210 descendants of its own.
- 10 other devices also cite its predicate K130573.
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?
Lumbar System Indications The Aurora Spine Interbody Fusion System devices are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirned by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-SI ). Patients should have six months of non-operative treatment prior to surgery. These…
Read the full statement (217 words)
Lumbar System Indications
The Aurora Spine Interbody Fusion System devices are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirned by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-SI ). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications
The Aurora Spine Interbody Fusion System is indicated for use as an intervenebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T I) and are placed via an anterior approach using autogenous hone. When used as an interhody fusion device, supplemental fixation must be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133967: Interbody Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133967
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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