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 Jan 25, 2017 as substantially equivalent to K073502 (Vertebron, Inc., 2008) and 6 other predicates after a 293-day review. Its family tree reaches back 15 generations to 1984. 1 of the 156 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Jan 25, 2017
- Review
- 293 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K841189 (1984). 147 ancestors in all. 8 later devices descend from it, 4 citing it directly. 1 of the 156 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK151140 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- This deviceK160976 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · cites it directly · 6 of its ownK170512 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · cites it directly · 2 of its ownK171329 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · cites it directly · 1 of its ownK182406 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK181829 Velofix TLIF CageU&I Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK211837 Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC · 2022
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 4 generations backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 3 generations backK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK151140 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- This deviceK160976 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 5 of 8 · See all- K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · cites it directly6descendants
- K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · cites it directly2descendants
- K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2019 · cites it directly1descendant
- K181829Velofix TLIF CageU&I Corporation · 2018 · 2 generations on1descendant
- K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −4 | K113528 | Clydesdale (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −3 | K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| −2 | K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| −1 | K151140 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015 | — |
| 0 (this device) | K160976 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +1 | K170512 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +1 | K171329 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +1 | K182406 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2019 | — |
| +2 | K181829 | Velofix TLIF Cage | U&I Corporation | 2018 | — |
| +2 | 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 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K073502 | Vertebron VBR SystemSummary page 4…January 23, 2017 COMMON NAME: Interbody Fusion Device PROPRIETARY NAME: Altus Spine Interbody Fusion System PRIMARY PREDICATE Vertebron Interbody Fusion System (K073502) DEVICE: ADDITIONAL PREDICATE Camber Spine Technologies TLS 5.0 Interbody Cage (K121254); LnK Lumbar… | 2008 |
| * | K121254 | Camber Spine Technologies TLS 5.0 Inerbody CageSummary page 4…ion System PRIMARY PREDICATE Vertebron Interbody Fusion System (K073502) DEVICE: ADDITIONAL PREDICATE Camber Spine Technologies TLS 5.0 Interbody Cage (K121254); LnK Lumbar DEVICES: Interbody Fusion Cage System (K151140); Interbody Innovation Zeus… | 2013 |
| * | K151140 | LnK Lumbar Interbody Fusion Cage SystemSummary page 4…DEVICE: ADDITIONAL PREDICATE Camber Spine Technologies TLS 5.0 Interbody Cage (K121254); LnK Lumbar DEVICES: Interbody Fusion Cage System (K151140); Interbody Innovation Zeus Intervertebral Fusion Devices (K081614); OsteoMed Spine PrimaLIF LLIF… | 2015 |
| * | K081614 | Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar CagesSummary page 4…(K121254); LnK Lumbar DEVICES: Interbody Fusion Cage System (K151140); Interbody Innovation Zeus Intervertebral Fusion Devices (K081614); OsteoMed Spine PrimaLIF LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System (K123207); Choice… | 2008 |
| * | K123207 | Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemSummary page 4…Intervertebral Fusion Devices (K081614); OsteoMed Spine PrimaLIF LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System (K123207); Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon) (K153107);… | 2012 |
| * | K153107 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™… Cleared while this submission was under review Summary page 4…Unitary PEEK Lateral Lumbar Interbody Fusion System (K123207); Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon) (K153107); SpineFrontier Lumbar IBF System (K111553) CLASSIFICATION NAME: 21 CFR §888.3080 Intervertebral Body Fu… | 2016 |
| * | K111553 | Spinefrontier Lumbar Ibf SystemSummary page 4…K123207); Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon) (K153107); SpineFrontier Lumbar IBF System (K111553) CLASSIFICATION NAME: 21 CFR §888.3080 Intervertebral Body Fusion Device PRODUCT CODES: MAX DEVICE CLASS: Class II… | 2011 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 33 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 16 of the 147 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170512 (Altus Partners, LLC, 2017) has gone furthest, with 6 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. 2017, 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…
Read the full statement (113 words)
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, such as the Altus
Spine Pedicle Screw System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160976: Altus Spine 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/K160976
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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