510(k) · Cleared
ClearedNavagio Lumbar Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kalitec Medical, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 27, 2022 as substantially equivalent to K123100 (Kalitec Direct, LLC, 2013) and 1 other predicate after a 60-day review. Its family tree reaches back 14 generations to 1984.
- Decided
- May 27, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K841189 (1984). 36 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK113447 Rise SpacerGlobus Medical, Inc. · 2012
- 2 generations backK123231 Caliber SpacersGlobus Medical, Inc. · 2013
- 1 generation backK152011 Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc. · 2016
- This deviceK220902 Navagio Lumbar CageKalitec Medical, LLC · 2022
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 backK113447 Rise SpacerGlobus Medical, Inc. · 2012
- 2 generations backK123231 Caliber SpacersGlobus Medical, Inc. · 2013
- 1 generation backK152011 Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc. · 2016
- This deviceK220902 Navagio Lumbar CageKalitec Medical, LLC · 2022
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 | K113447 | Rise Spacer | Globus Medical, Inc. | 2012 | — |
| −2 | K123231 | Caliber Spacers | Globus Medical, Inc. | 2013 | — |
| −1 | K152011 | Lucent Intervertebral Body Fusion Device | Spinal Elements, Inc. | 2016 | — |
| 0 (this device) | K220902 | Navagio Lumbar Cage | Kalitec Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K123100 | Intess Lumbar CageSummary page 4…Device panel: Orthopedic Primary Legally Marketed Predicate Device: InTess Lumbar Cage – Kalitec Direct (K123100) Secondary Legally Marketed Predicate Devices Lucent Lumbar Interbody System- Sp… | 2013 |
| * | K152011 | Lucent Intervertebral Body Fusion DeviceSummary page 4…– Kalitec Direct (K123100) Secondary Legally Marketed Predicate Devices Lucent Lumbar Interbody System- Spinal Elements (K152011) Submitter: Kalitec Direct, LLC doing business as Kalitec Medical 618 E. S… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 36 ancestors have a recall of any class.
- 1 other device also cites its predicate K123100.
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. 2022, 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 Navagio Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).…
Read the full statement (137 words)
The Navagio Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
Navagio Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The Navagio Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220902: Navagio Lumbar Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220902
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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