510(k) · Cleared
ClearedPlateau Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 15, 2008 after a 90-day review. The FDA summary names no predicate by number. 1 of the 765 devices in its family, counting itself, has a Class I recall. 764 later devices descend from it.
- Decided
- May 15, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
764 later devices descend from it, 15 citing it directly. 1 of the 765 devices in this family, counting this one, has a Class I recall.
- This deviceK080411 Plateau Spacer SystemLife Spine · 2008
- Descendant · cites it directly · 637 of its ownK100865 Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine · 2010
- Descendant · 2 generations on · 636 of its ownK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- Descendant · cites it directly · 473 of its ownK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- Descendant · 3 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- Descendant · 2 generations on · 461 of its ownK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
Showing 5 of 764 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 764 · See all- K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine · 2010 · cites it directly637descendants
- K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation · 2015 · 2 generations on636descendants
- K091301Life Spine Stand-Alone Spacer SystemLife Spine · 2009 · cites it directly473descendants
- K143616AccuLIF TL and PL CageStryker Corporation · 2015 · 3 generations on469descendants
- K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010 · 2 generations on461descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080411 | Plateau Spacer System | Life Spine | 2008 | — |
| +1 | K100865 | Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX | Stryker Spine | 2010 | — |
| +2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| +1 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| +3 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| +2 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 10 | 0 |
| 2016 | 29 | 0 |
| 2017 | 51 | 0 |
| 2018 | 54 | 0 |
| 2019 | 69 | 0 |
| 2020 | 80 | 0 |
| 2021 | 66 | 1 |
| 2022 | 73 | 0 |
| 2023 | 87 | 0 |
| 2024 | 91 | 0 |
| 2025 | 74 | 0 |
| 2026 | 66 | 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?
The FDA summary names no predicate by number.
What descends from it? (764)
See all 76415 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100865 | Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX | 2010 | 637 |
| K091301 | Life Spine Stand-Alone Spacer System | 2009 | 473 |
| K111569 | Plateau Spacer System | 2011 | 181 |
| K191005 | ProLift® Expandable System | 2019 | 18 |
| K130630 | Plateau Spacer System Titanium | 2013 | 17 |
| K190488 | ProLift Expandable System | 2019 | 16 |
| K121116 | Plateau Spacer System | 2012 | 13 |
| K201721 | TruLift Expandable Spacer System | 2020 | 5 |
| K210061 | ProLift Lateral HELO Fixated | 2021 | 3 |
| K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer | 2020 | 3 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K100865 (Stryker Spine, 2010) has gone furthest, with 637 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. 2008, 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 Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080411: Plateau Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080411
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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