510(k) · Cleared
ClearedProLift Micro Expandable Spacer System
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 May 4, 2023 as substantially equivalent to K153400 (Life Spine, Inc., 2016) and 1 other predicate after a 171-day review. Its family tree reaches back 16 generations to 1984. 6 later devices descend from it.
- Decided
- May 4, 2023
- Review
- 171 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K841189 (1984). 75 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 2 generations backK133813 Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc. · 2014
- 1 generation backK153400 ProLift Expandable SystemLife Spine, Inc. · 2016
- This deviceK223430 ProLift Micro Expandable Spacer SystemLife Spine, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK232611 TruLift Micro Expandable Spacer System & TruLift Expandable Spacer…Life Spine, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK250373 ProLift Expandable Spacer SystemLife Spine, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261430 TruLift Expandable SystemLife Spine, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260837 VersaLift Expandable SystemLife Spine, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253748 Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated…Life Spine, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 6 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 5 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 4 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 3 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 2 generations backK133813 Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc. · 2014
- 1 generation backK153400 ProLift Expandable SystemLife Spine, Inc. · 2016
- This deviceK223430 ProLift Micro Expandable Spacer SystemLife Spine, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −6 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −5 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −4 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −3 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −2 | K133813 | Flxfit Intervertebral Body Fusion Device | Expanding Orthopedics, Inc. | 2014 | — |
| −1 | K153400 | ProLift Expandable System | Life Spine, Inc. | 2016 | — |
| 0 (this device) | K223430 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | 2023 | — |
| +1 | K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | Life Spine, Inc. | 2023 | — |
| +1 | K250373 | ProLift Expandable Spacer System | Life Spine, Inc. | 2025 | — |
| +2 | K261430 | TruLift Expandable System | Life Spine, Inc. | 2026 | — |
| +1 | K260837 | VersaLift Expandable System | Life Spine, Inc. | 2026 | — |
| +2 | K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable… | Life Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K212520 | FDA’s K212520 is ProLift Micro Expandable Spacer System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2021 |
| Kept off the family tree | K190488 | FDA’s K190488 is ProLift Expandable System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2019 |
| * | K153400 | ProLift Expandable SystemSummary page 4…System (K) Additional Predicate: /LIH6SLQH3UR/LIW([SDQGDEOH6\VWHP . Life Spine ProLift Expandable Spacer System (K153400) Globus Rise Spacer System (K113447) Device Description: The ProLift® Micro Expandable System is a… | 2016 |
| * | K113447 | Rise SpacerSummary page 4…W([SDQGDEOH6\VWHP . 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… | 2012 |
What descends from it? (6)
4 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 39 years and passes through 12 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 75 ancestors have a recall of any class.
- Of its descendants, K232611 (Life Spine, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K153400.
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. 2023, 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?
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.
https://510kreport.com/device/K223430 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223430: ProLift Micro Expandable Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223430
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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