510(k) · Cleared
ClearedAUDERE Lumbar Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Met One Technologies · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 12, 2020 as substantially equivalent to K160699 (Met 1 Technologies, LLC, 2016) and 3 other predicates after a 148-day review. Its family tree reaches back 14 generations to 1984. 1 later device descends from it.
- Decided
- May 12, 2020
- Review
- 148 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K841189 (1984). 89 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK122097 Patriot SpacersGlobus Medical, Inc. · 2012
- 1 generation backK160699 VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC · 2016
- This deviceK193457 AUDERE Lumbar Spacer SystemMet One Technologies · 2020
- Descendant · cites it directly · 0 of its ownK230851 Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 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 backK113447 Rise SpacerGlobus Medical, Inc. · 2012
- 2 generations backK122097 Patriot SpacersGlobus Medical, Inc. · 2012
- 1 generation backK160699 VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC · 2016
- This deviceK193457 AUDERE Lumbar Spacer SystemMet One Technologies · 2020
Most influential descendants
Showing 1 of 1 · See all- K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 2023 · cites it directly0descendants
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 | K122097 | Patriot Spacers | Globus Medical, Inc. | 2012 | — |
| −1 | K160699 | VIRTU Lumbar Spacer System | Met 1 Technologies, LLC | 2016 | — |
| 0 (this device) | K193457 | AUDERE Lumbar Spacer System | Met One Technologies | 2020 | — |
| +1 | K230851 | Kodiak Lumbar Spacer System | Met One Technologies, LLC | 2023 | — |
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 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 10 | 0 |
| 2005 | 8 | 0 |
| 2006 | 1 | 0 |
| 2007 | 8 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K160699 | VIRTU Lumbar Spacer SystemSummary page 5…Page 1 of 2 Primary Predicate AUDERE Lumbar Spacer System (Met One Technologies, LLC – K160699) Additional Predicates PATRIOTTM Spacer (Globus Medical Inc. – K122097) Interbody System (Tyber Medica… | 2016 |
| * | K122097 | Patriot SpacersSummary page 5…Primary Predicate AUDERE Lumbar Spacer System (Met One Technologies, LLC – K160699) Additional Predicates PATRIOTTM Spacer (Globus Medical Inc. – K122097) Interbody System (Tyber Medical – K130573) AccuLiF® TL-PEEK Cage and AccuLiF® TL… | 2012 |
| * | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifSummary page 5…(Met One Technologies, LLC – K160699) Additional Predicates PATRIOTTM Spacer (Globus Medical Inc. – K122097) Interbody System (Tyber Medical – K130573) AccuLiF® TL-PEEK Cage and AccuLiF® TL and PL (CoALign Innovation – K112095) Performance Data: THE… | 2013 |
| * | K112095 | Acculif TL-Peek Ibf CageSummary page 5…– K122097) Interbody System (Tyber Medical – K130573) AccuLiF® TL-PEEK Cage and AccuLiF® TL and PL (CoALign Innovation – K112095) Performance Data: THE AUDERE Lumbar Spacer System has been tested in the following test modes:… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230851 | Kodiak Lumbar Spacer 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 36 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 10 of the 89 ancestors have a recall of any class.
- Of its descendants, K230851 (Met One Technologies, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K160699.
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. 2020, 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 AUDERE Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the…
Read the full statement (142 words)
The AUDERE Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with
degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1
spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of
the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved
level may be treated with the AUDERE Lumbar Spacer System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with
the AUDERE Lumbar Spacer System.
The AUDERE Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to
be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193457 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193457: AUDERE Lumbar Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193457
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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