510(k) · Cleared
ClearedLife Spine Plateau 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 Jul 17, 2013 as substantially equivalent to K121116 (Life Spine, 2012) and 1 other predicate after a 91-day review. Its family tree reaches back 12 generations to 1984. 10 later devices descend from it.
- Decided
- Jul 17, 2013
- Review
- 91 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K841189 (1984). 69 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 2 generations backK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
- 1 generation backK121116 Plateau Spacer SystemLife Spine · 2012
- This deviceK131077 Life Spine Plateau Spacer SystemLife Spine · 2013
- Descendant · cites it directly · 9 of its ownK133717 Longbow Spacer SystemLife Spine · 2014
- Descendant · 2 generations on · 5 of its ownK201721 TruLift Expandable Spacer SystemLife Spine, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK210061 ProLift Lateral HELO FixatedLife Spine, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK221806 TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK170919 The TiBow Expandable Spacer SystemLife Spine, Inc. · 2017
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 2 generations backK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
- 1 generation backK121116 Plateau Spacer SystemLife Spine · 2012
- This deviceK131077 Life Spine Plateau Spacer SystemLife Spine · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K133717Longbow Spacer SystemLife Spine · 2014 · cites it directly9descendants
- K201721TruLift Expandable Spacer SystemLife Spine, Inc. · 2020 · 2 generations on5descendants
- K210061ProLift Lateral HELO FixatedLife Spine, Inc. · 2021 · 3 generations on3descendants
- K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022 · 3 generations on1descendant
- K170919The TiBow Expandable Spacer SystemLife Spine, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K073177 | Pioneer Intervertebral Fusion Device System | Pioneer Surgical Technology | 2008 | 1 |
| −2 | K112496 | Pioneer Crossfuse II Ibf/VBR System | Pioneer Surgical Technology, Inc. | 2011 | — |
| −1 | K121116 | Plateau Spacer System | Life Spine | 2012 | — |
| 0 (this device) | K131077 | Life Spine Plateau Spacer System | Life Spine | 2013 | — |
| +1 | K133717 | Longbow Spacer System | Life Spine | 2014 | — |
| +2 | K201721 | TruLift Expandable Spacer System | Life Spine, Inc. | 2020 | — |
| +3 | K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | 2021 | — |
| +3 | K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | 2022 | — |
| +2 | K170919 | The TiBow Expandable Spacer System | Life Spine, Inc. | 2017 | — |
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 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 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? (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 |
|---|---|---|---|
| * | K121116 | Plateau Spacer SystemSummary page 1…n Name: Intervertebral Body Fusion Device Classification: MAX, 21 CER 888.3080, Class II Predicate Device: Plateau Spacer System (K 121 116) and The HONOUR Spacer System (K 120345) Device Description: The Plateau Spacer System is intend… | 2012 |
| * | K120345 | Honour Spacer SystemSummary page 1…ion: MAX, 21 CER 888.3080, Class II Predicate Device: Plateau Spacer System (K 121 116) and The HONOUR Spacer System (K 120345) Device Description: The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is… | 2012 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133717 | Longbow Spacer System | 2014 | 9 |
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 29 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 69 ancestors have a recall of any class.
- Of its descendants, K133717 (Life Spine, 2014) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K121116.
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…
Read the full statement (187 words)
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.
The Plateau-C Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131077: Life Spine 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/K131077
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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