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 Apr 10, 2017 after a 129-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Apr 10, 2017
- Review
- 129 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK163386 Keos Lumbar IBFDKeos · 2017
- Descendant · cites it directly · 0 of its ownK193174 Keos Lumbar IBFDKeos · 2019
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 |
|---|---|---|---|---|---|
| 0 (this device) | K163386 | Keos Lumbar IBFD | Keos | 2017 | — |
| +1 | K193174 | Keos Lumbar IBFD | Keos | 2019 | — |
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? (1)
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 |
|---|---|---|---|
| Kept off the family tree | K160631 | FDA’s K160631 is Keos Lumbar IBFD Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2016 |
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?
- Of its descendants, K193174 (Keos, 2019) has gone furthest, with 0 descendants of its own.
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?
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/K163386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163386: Keos Lumbar IBFD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163386
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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