510(k) · Cleared
ClearedLife Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer
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 Aug 4, 2020 as substantially equivalent to K080411 (Life Spine, 2008) and 5 other predicates after a 60-day review. Its family tree reaches back 26 generations to 1984. 1 of the 417 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Aug 4, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 26 generations to K841189 (1984). 413 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 2 citing it directly. 1 of the 417 devices in this family, counting this one, has a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 1 generation backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- This deviceK201500 Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti…Life Spine, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK221806 TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK251502 TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK213417 Ghost Spacer SystemLife Spine, Inc. · 2022
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 6 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 5 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 4 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 3 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 1 generation backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- This deviceK201500 Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti…Life Spine, Inc. · 2020
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
Most influential descendants
Showing 3 of 3 · See all- K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022 · cites it directly1descendant
- K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc. · 2025 · 2 generations on0descendants
- K213417Ghost Spacer SystemLife Spine, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −4 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −3 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −2 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −1 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| 0 (this device) | K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar… | Life Spine, Inc. | 2020 | — |
| +1 | K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | 2022 | — |
| +2 | K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. | 2025 | — |
| +1 | K213417 | Ghost Spacer System | Life Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 15 | 0 |
| 2002 | 13 | 0 |
| 2003 | 19 | 0 |
| 2004 | 30 | 0 |
| 2005 | 22 | 0 |
| 2006 | 16 | 0 |
| 2007 | 18 | 0 |
| 2008 | 49 | 1 |
| 2009 | 30 | 0 |
| 2010 | 18 | 0 |
| 2011 | 25 | 0 |
| 2012 | 16 | 0 |
| 2013 | 21 | 0 |
| 2014 | 20 | 0 |
| 2015 | 12 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2025 | 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.
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? (6)
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 4…Lumbar Spacer Common Name: Interbody Fusion Device Classification: MAX, CFR 888.3080, Class II Primary Predicate: Life Spine Plateau (K080411/K111569) Secondary Predicate: Life Spine Plateau Ti (K130630) Life Spine Plateau-X Spacer Syste… | 2008 |
| * | K111569 | Plateau Spacer SystemSummary page 4…pacer Common Name: Interbody Fusion Device Classification: MAX, CFR 888.3080, Class II Primary Predicate: Life Spine Plateau (K080411/K111569) Secondary Predicate: Life Spine Plateau Ti (K130630) Life Spine Plateau-X Spacer System (K1211… | 2011 |
| * | K130630 | Plateau Spacer System TitaniumSummary page 4…lassification: MAX, CFR 888.3080, Class II Primary Predicate: Life Spine Plateau (K080411/K111569) Secondary Predicate: Life Spine Plateau Ti (K130630) Life Spine Plateau-X Spacer System (K121116) AlphaTec Holdings Indenti TI… | 2013 |
| * | K121116 | Plateau Spacer SystemSummary page 4…: Life Spine Plateau (K080411/K111569) Secondary Predicate: Life Spine Plateau Ti (K130630) Life Spine Plateau-X Spacer System (K121116) AlphaTec Holdings Indenti TI Porous Ti Interbody System (K183705) Alpha Te… | 2012 |
| * | K183705 | IdentiTi Porous Ti Interbody SystemSummary page 4…Ti (K130630) Life Spine Plateau-X Spacer System (K121116) AlphaTec Holdings Indenti TI Porous Ti Interbody System (K183705) Alpha Tec Holdings Lateral Interbody System (K191311) Device Description: The PLATEAU-A Ti Anterio… | 2019 |
| * | K191311 | ATEC Lateral Interbody SystemSummary page 4…116) AlphaTec Holdings Indenti TI Porous Ti Interbody System (K183705) Alpha Tec Holdings Lateral Interbody System (K191311) Device Description: The PLATEAU-A Ti Anterior Lumbar Spacer implants are intervertebral body fusion devices comprised of a va… | 2019 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 46 of the 413 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K221806 (Life Spine, Inc., 2022) has gone furthest, with 1 descendant 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. 2020, 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-A Ti Anterior Lumbar Spacer 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…
Read the full statement (246 words)
The PLATEAU-A Ti Anterior Lumbar Spacer 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone 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-X Ti Lateral Lumbar Spacer 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone 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/K201500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201500: Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201500
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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