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 8, 2012 as substantially equivalent to K080411 (Life Spine, 2008) and 2 other predicates after a 26-day review. Its family tree reaches back 11 generations to 1984. 13 later devices descend from it.
- Decided
- May 8, 2012
- Review
- 26 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 37 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 1 generation backK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
- This deviceK121116 Plateau Spacer SystemLife Spine · 2012
- Descendant · cites it directly · 10 of its ownK131077 Life Spine Plateau Spacer SystemLife Spine · 2013
- Descendant · 2 generations on · 9 of its ownK133717 Longbow Spacer SystemLife Spine · 2014
- Descendant · 3 generations on · 5 of its ownK201721 TruLift Expandable Spacer SystemLife Spine, Inc. · 2020
- Descendant · 4 generations on · 3 of its ownK210061 ProLift Lateral HELO FixatedLife Spine, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK201500 Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti…Life Spine, Inc. · 2020
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 1 generation backK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
- This deviceK121116 Plateau Spacer SystemLife Spine · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K131077Life Spine Plateau Spacer SystemLife Spine · 2013 · cites it directly10descendants
- K133717Longbow Spacer SystemLife Spine · 2014 · 2 generations on9descendants
- K201721TruLift Expandable Spacer SystemLife Spine, Inc. · 2020 · 3 generations on5descendants
- K210061ProLift Lateral HELO FixatedLife Spine, Inc. · 2021 · 4 generations on3descendants
- K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc. · 2020 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K073177 | Pioneer Intervertebral Fusion Device System | Pioneer Surgical Technology | 2008 | 1 |
| −1 | K112496 | Pioneer Crossfuse II Ibf/VBR System | Pioneer Surgical Technology, Inc. | 2011 | — |
| 0 (this device) | K121116 | Plateau Spacer System | Life Spine | 2012 | — |
| +1 | K131077 | Life Spine Plateau Spacer System | Life Spine | 2013 | — |
| +2 | K133717 | Longbow Spacer System | Life Spine | 2014 | — |
| +3 | K201721 | TruLift Expandable Spacer System | Life Spine, Inc. | 2020 | — |
| +4 | K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | 2021 | — |
| +1 | K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar… | Life Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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…on Name: Intervertebral Body Fusion Device Classification: MAX, 21 CFR 888.3080, Class II Predicate Device: Plateau Spacer System (K08041 1), Nuvasive CoRoent (K07 1795), Pioneer CrossFuse (KI 12496) Device Description: The Plateau Spacer… | 2008 |
| * | K071795 | Nuvasive Coroent SystemSummary page 1…vertebral Body Fusion Device Classification: MAX, 21 CFR 888.3080, Class II Predicate Device: Plateau Spacer System (K08041 1), Nuvasive CoRoent (K07 1795), Pioneer CrossFuse (KI 12496) Device Description: The Plateau Spacer System is intended to serve… | 2007 |
| * | K112496 | Pioneer Crossfuse II Ibf/VBR System | 2011 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 5 of the 37 ancestors have a recall of any class.
- Of its descendants, K131077 (Life Spine, 2013) has gone furthest, with 10 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. 2012, 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 (DOD) at one or two contiguous levels (L2-S 1). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ODD 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 as stated in the FDA summary.
https://510kreport.com/device/K121116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121116: 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/K121116
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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