510(k) Report

510(k) · Cleared

Cleared

ProLift Micro Expandable Spacer System

K212520510(k) TraditionalCleared Oct 8, 202159-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Life Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Oct 8, 2021 as substantially equivalent to K190488 (Life Spine, Inc., 2019) and 3 other predicates after a 59-day review. Its family tree reaches back 18 generations to 1984. 6 later devices descend from it.

Decided
Oct 8, 2021
Review
59 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
4

Its longest line of descent runs back 18 generations to K841189 (1984). 153 ancestors in all. 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 4 other ancestors2015: 1 other ancestor2013: 8 other ancestors2011: 9 other ancestors2010: 9 other ancestors2009: 10 other ancestors2008: 24 other ancestors2014: 3 other ancestors2007: 11 other ancestors2003: 11 other ancestors2000: 1 other ancestor2006: 3 other ancestors2005: 8 other ancestors2002: 8 other ancestors2001: 10 other ancestors1999: 2 other ancestors2004: 11 other ancestors1996: 2 other ancestors2025: 2 descendants cleared2023: 1 descendant cleared2026: 3 descendants clearedReference device: K191005 · ProLift® Expandable System · Life Spine, Inc. · 2019K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K133813 · Flxfit Intervertebral Body Fusion Device · Expanding Orthopedics, Inc. · 2014K153400 · ProLift Expandable System · Life Spine, Inc. · 2016K173182 · ProLift® Expandable System · Life Spine, Inc. · 2017K190488 · ProLift Expandable System · Life Spine, Inc. · 201919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 8 other ancestors3 generations back: 21 other ancestors4 generations back: 38 other ancestors5 generations back: 32 other ancestors6 generations back: 21 other ancestors7 generations back: 10 other ancestors8 generations back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants K190488 · ProLift Expandable System · Life Spine, Inc. · 2019K173182 · ProLift® Expandable System · Life Spine, Inc. · 2017K153400 · ProLift Expandable System · Life Spine, Inc. · 2016K133813 · Flxfit Intervertebral Body Fusion Device · Expanding Orthopedics, Inc. · 2014K123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−15−10−50
  1. Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 14 generations between
  3. 3 generations backK153400 ProLift Expandable SystemLife Spine, Inc. · 2016
  4. 2 generations backK173182 ProLift® Expandable SystemLife Spine, Inc. · 2017
  5. 1 generation backK190488 ProLift Expandable SystemLife Spine, Inc. · 2019
  6. This deviceK212520 ProLift Micro Expandable Spacer SystemLife Spine, Inc. · 2021
  7. Descendant · cites it directly · 2 of its ownK232611 TruLift Micro Expandable Spacer System & TruLift Expandable Spacer…Life Spine, Inc. · 2023
  8. Descendant · cites it directly · 1 of its ownK250373 ProLift Expandable Spacer SystemLife Spine, Inc. · 2025
  9. Descendant · 2 generations on · 0 of its ownK261430 TruLift Expandable SystemLife Spine, Inc. · 2026
  10. Descendant · cites it directly · 0 of its ownK260837 VersaLift Expandable SystemLife Spine, Inc. · 2026
  11. Descendant · 2 generations on · 0 of its ownK253748 Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated…Life Spine, Inc. · 2026
Show all 18 generations
  1. Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 8 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 7 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 6 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 5 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 4 generations backK133813 Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc. · 2014
  16. 3 generations backK153400 ProLift Expandable SystemLife Spine, Inc. · 2016
  17. 2 generations backK173182 ProLift® Expandable SystemLife Spine, Inc. · 2017
  18. 1 generation backK190488 ProLift Expandable SystemLife Spine, Inc. · 2019
  19. This deviceK212520 ProLift Micro Expandable Spacer SystemLife Spine, Inc. · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2023: 12025: 22026: 3
2023high 3 (2026) · low 0 (2024)2026

Most influential descendants

Showing 5 of 6 · See all
  • K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc. · 2023 · cites it directly2descendants
  • K250373ProLift Expandable Spacer SystemLife Spine, Inc. · 2025 · cites it directly1descendant
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026 · 2 generations on0descendants
  • K260837VersaLift Expandable SystemLife Spine, Inc. · 2026 · cites it directly0descendants
  • K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−17K990148Stackable Cage SystemDepuy Motech Acromed1999—
−16K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−15K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−14K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−13K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−12K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−11K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−10K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−9K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−8K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−7K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−6K121683Acculif TL CageCoalign Innovations, Inc.2012—
−5K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−4K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014—
−3K153400ProLift Expandable SystemLife Spine, Inc.2016—
−2K173182ProLift® Expandable SystemLife Spine, Inc.2017—
−1K190488ProLift Expandable SystemLife Spine, Inc.2019—
0 (this device)K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.2021—
+1K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.2023—
+1K250373ProLift Expandable Spacer SystemLife Spine, Inc.2025—
+2K261430TruLift Expandable SystemLife Spine, Inc.2026—
+1K260837VersaLift Expandable SystemLife Spine, Inc.2026—
+2K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable…Life Spine, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
2001100
200280
2003110
2004110
200580
200630
2007110
2008240
2009100
201090
201190
201240
201380
201430
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202520
202630
FIG. 1 — Lineage of K212520, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K190488ProLift Expandable System
Summary page 4
…Intervertebral Body Fusion Device Classification: MAX, CFR 888.3080, Class II Primary Predicate: Life Spine ProLift Expandable System (K190488) Additional Predicate: Life Spine ProLift Expandable System (K173182) Life Spine ProLift Exp…
Life Spine, Inc.2019—
*K173182ProLift® Expandable System
Summary page 4
…, CFR 888.3080, Class II Primary Predicate: Life Spine ProLift Expandable System (K190488) Additional Predicate: Life Spine ProLift Expandable System (K173182) Life Spine ProLift Expandable Spacer System (K153400) Globus Rise Spac…
Life Spine, Inc.2017—
*K153400ProLift Expandable System
Summary page 4
…e System (K190488) Additional Predicate: Life Spine ProLift Expandable System (K173182) Life Spine ProLift Expandable Spacer System (K153400) Globus Rise Spacer System (K113447) Device Description: The ProLift® Micro Expandable System is a…
Life Spine, Inc.2016—
*K113447Rise Spacer
Summary page 4
…ft Expandable System (K173182) Life Spine ProLift Expandable Spacer System (K153400) Globus Rise Spacer System (K113447) Device Description: The ProLift® Micro Expandable System is available in a range of sizes and footprints and can expand to the…
Globus Medical, Inc.2012—
†K191005ProLift® Expandable SystemLife Spine, Inc.2019—

Also cleared against K190488: 8 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232
K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251
K260837VersaLift Expandable SystemLife Spine, Inc.20260
K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250

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 37 years and passes through 12 companies; a new generation was cleared every 1.6 years on median.
  • 19 of the 153 ancestors have a recall of any class.
  • Of its descendants, K232611 (Life Spine, Inc., 2023) has gone furthest, with 2 descendants of its own.
  • 8 other devices also cite its predicate K190488.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

When used as an interbody fusion device, the ProLift® Micro Expandable 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…

Read the full statement (144 words)

When used as an interbody fusion device, the ProLift® Micro Expandable 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. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. 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 as stated in the FDA summary.

Cite this page

510(k) Report. “K212520: ProLift Micro Expandable Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212520

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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