510(k) · Cleared
ClearedAltus Spine Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altus Partners, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Feb 22, 2019 as substantially equivalent to K073502 (Vertebron, Inc., 2008) and 2 other predicates after a 171-day review. Its family tree reaches back 18 generations to 1984. 1 of the 154 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Feb 22, 2019
- Review
- 171 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K841189 (1984). 152 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 154 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK160976 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
- 2 generations backK170512 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- 1 generation backK171329 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- This deviceK182406 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2019
- Descendant · cites it directly · 0 of its ownK211837 Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC · 2022
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 7 generations backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 5 generations backK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 4 generations backK151140 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- 3 generations backK160976 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
- 2 generations backK170512 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- 1 generation backK171329 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- This deviceK182406 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2019
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −7 | K113528 | Clydesdale (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| −5 | K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| −4 | K151140 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015 | — |
| −3 | K160976 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| −2 | K170512 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| −1 | K171329 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| 0 (this device) | K182406 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2019 | — |
| +1 | K211837 | Altus Spine Interbody Standalone Fusion System | Altus Partners, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 14 | 0 |
| 2005 | 12 | 0 |
| 2006 | 3 | 0 |
| 2007 | 10 | 0 |
| 2008 | 20 | 1 |
| 2009 | 11 | 0 |
| 2010 | 8 | 0 |
| 2011 | 8 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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.
1 device in this family has a Class I recall. 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073502 | Vertebron VBR SystemSummary page 4…nterbody Fusion Device PROPRIETARY NAME: Altus Spine Titanium Interbody Fusion System PRIMARY PREDICATE DEVICES: Vertebron Interbody Fusion System (K073502) ADDITIONAL PREDICATE DEVICES: Altus Spine Interbody Fusion System (K160976) Altus Spine In… | 2008 |
| * | K160976 | Altus Spine Interbody Fusion SystemSummary page 4…rbody Fusion System PRIMARY PREDICATE DEVICES: Vertebron Interbody Fusion System (K073502) ADDITIONAL PREDICATE DEVICES: Altus Spine Interbody Fusion System (K160976) Altus Spine Interbody Fusion System (K171329) Xenco Medi… | 2017 |
| * | K171329 | Altus Spine Titanium Interbody Fusion SystemSummary page 4…n System (K073502) ADDITIONAL PREDICATE DEVICES: Altus Spine Interbody Fusion System (K160976) Altus Spine Interbody Fusion System (K171329) Xenco Medical Set-X Hyperlordotic Implant (K141358) CLASSIFICATION NAME: 21 CFR… | 2017 |
| Kept off the family tree | K141358 | FDA’s K141358 is Cellvizio 100 Series with System Confocal Miniprobes Our reading of the summary gave K141358, FDA’s number for Cellvizio 100 Series with System Confocal Miniprobes (Mauna Kea Technologies). Its FDA name has none of the distinctive words the summary uses for the device it names, “Xenco Medical Set-X Hyperlordotic Implant”. Kept off the family tree. Summary page 4…K160976) Altus Spine Interbody Fusion System (K171329) Xenco Medical Set-X Hyperlordotic Implant (K141358) CLASSIFICATION NAME: 21 CFR §888.3080 Intervertebral Body Fusion Device PRODUCT CODES: MAX… | 2014 |
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 |
|---|---|---|---|
| K211837 | Altus Spine Interbody Standalone Fusion System | 2022 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 16 of the 152 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K211837 (Altus Partners, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K073502.
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. 2019, 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 Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The Altus Spine Interbody Fusion System is to be combined with cleared supplemental fixation systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182406: Altus Spine Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182406
Report an extraction error
Are you the manufacturer?
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