510(k) · Cleared
ClearedKeos Lumbar IBFD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keos · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 15, 2016 as substantially equivalent to K080281 (Custom Spine, Inc., 2008) and 1 other predicate after a 130-day review. Its family tree reaches back 13 generations to 1984. 1 later device descends from it.
- Decided
- Jul 15, 2016
- Review
- 130 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K841189 (1984). 65 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 2 generations backK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 1 generation backK150321 EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2015
- This deviceK160631 Keos Lumbar IBFDKeos · 2016
- Descendant · cites it directly · 0 of its ownK193174 Keos Lumbar IBFDKeos · 2019
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 2 generations backK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 1 generation backK150321 EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2015
- This deviceK160631 Keos Lumbar IBFDKeos · 2016
Most influential descendants
Showing 1 of 1 · See all- K193174Keos Lumbar IBFDKeos · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −2 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −1 | K150321 | EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | 2015 | — |
| 0 (this device) | K160631 | Keos Lumbar IBFD | Keos | 2016 | — |
| +1 | K193174 | Keos Lumbar IBFD | Keos | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K080281 | PathwaySummary page 4…Device and Number 21 CFR 888.3080 Classification Panel: Orthopedic Product Code MAX Reason for 510k New Device Primary Predicate K080281, Custom Spine Pathway Additional Predicate K150321, EVOS Lumbar Interbody System Device for Material Device Description… | 2008 |
| * | K150321 | EVOS Lumbar Interbody SystemSummary page 4…fication Panel: Orthopedic Product Code MAX Reason for 510k New Device Primary Predicate K080281, Custom Spine Pathway Additional Predicate K150321, EVOS Lumbar Interbody System Device for Material Device Description The series of intervertebral body fusion devices are… | 2015 |
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 |
|---|---|---|---|
| K193174 | Keos Lumbar IBFD | 2019 | 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 32 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 65 ancestors have a recall of any class.
- Of its descendants, K193174 (Keos, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K080281.
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. 2016, 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?
Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved…
Read the full statement (206 words)
Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft.
Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Keos Lumbar IBFD can be used in one of two methods:
Transforaminal Lumbar Interbody Fusion (TLIF)
Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery.
Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160631 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160631: Keos Lumbar IBFD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160631
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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