510(k) · Cleared
ClearedPlateau Spacer System Titanium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 13, 2013 as substantially equivalent to K080411 (Life Spine, 2008) and 1 other predicate after a 97-day review. Its family tree reaches back 3 generations to 2007. 17 later devices descend from it.
- Decided
- Jun 13, 2013
- Review
- 97 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K071922 (2007). 4 ancestors in all. 17 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK071922 Interplate Interbody Fusion Device, Models C, CGC, L and LGCRsb Spine, LLC · 2007
- 2 generations backK071795 Nuvasive Coroent SystemNuvasive, Inc. · 2007
- 1 generation backK120918 Nuvasive Coroent Titanium SystemNuvasive, Inc. · 2012
- This deviceK130630 Plateau Spacer System TitaniumLife Spine, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK170512 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · cites it directly · 3 of its ownK201500 Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti…Life Spine, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK171329 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK221806 TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK193521 Steerable Plateau TiLife Spine, Inc. · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · cites it directly6descendants
- K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc. · 2020 · cites it directly3descendants
- K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · 2 generations on2descendants
- K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022 · 2 generations on1descendant
- K193521Steerable Plateau TiLife Spine, Inc. · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K071922 | Interplate Interbody Fusion Device, Models C, CGC, L and LGC | Rsb Spine, LLC | 2007 | — |
| −2 | K071795 | Nuvasive Coroent System | Nuvasive, Inc. | 2007 | — |
| −1 | K120918 | Nuvasive Coroent Titanium System | Nuvasive, Inc. | 2012 | — |
| 0 (this device) | K130630 | Plateau Spacer System Titanium | Life Spine, Inc. | 2013 | — |
| +1 | K170512 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +1 | K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar… | Life Spine, Inc. | 2020 | — |
| +2 | K171329 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +2 | K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | 2022 | — |
| +1 | K193521 | Steerable Plateau Ti | Life Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K080411 | Plateau Spacer SystemSummary page 1…ine Plateau Spacer System Titanium Common Name: Intervertebral Body Fusion Device Classification: MAX, 21 CFR 888.3080, Class II Predicate Device: Plateau Spacer System (K080411) Nuvasive CoRoent Titanium System (K120918) Device Description: The Plateau Spacer System is intended to serve as an intervert… | 2008 |
| * | K120918 | Nuvasive Coroent Titanium SystemSummary page 1…me: Intervertebral Body Fusion Device Classification: MAX, 21 CFR 888.3080, Class II Predicate Device: Plateau Spacer System (K080411) Nuvasive CoRoent Titanium System (K120918) Device Description: The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is ava… | 2012 |
What descends from it? (17)
See all 176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170512 | Altus Spine Titanium Interbody Fusion System | 2017 | 6 |
| K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer | 2020 | 3 |
| K193521 | Steerable Plateau Ti | 2020 | 1 |
| K170919 | The TiBow Expandable Spacer System | 2017 | 1 |
| K181625 | Life Spine Resolute™ Threaded Cage System | 2018 | 0 |
| K182470 | Plateau Spacer System | 2018 | 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 6 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K170512 (Altus Partners, LLC, 2017) has gone furthest, with 6 descendants of its own.
- 14 other devices also cite its predicate K080411.
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. 2013, 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 I 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 (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130630 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130630: Plateau Spacer System Titanium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130630
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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