510(k) · Cleared
ClearedProLift 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 Apr 9, 2025 as substantially equivalent to K190488 (Life Spine, Inc., 2019) and 2 other predicates after a 58-day review. Its family tree reaches back 19 generations to 1984. 1 later device descends from it.
- Decided
- Apr 9, 2025
- Review
- 58 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K841189 (1984). 155 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK173182 ProLift® Expandable SystemLife Spine, Inc. · 2017
- 2 generations backK190488 ProLift Expandable SystemLife Spine, Inc. · 2019
- 1 generation backK212520 ProLift Micro Expandable Spacer SystemLife Spine, Inc. · 2021
- This deviceK250373 ProLift Expandable Spacer SystemLife Spine, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253748 Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated…Life Spine, Inc. · 2026
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK133813 Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc. · 2014
- 4 generations backK153400 ProLift Expandable SystemLife Spine, Inc. · 2016
- 3 generations backK173182 ProLift® Expandable SystemLife Spine, Inc. · 2017
- 2 generations backK190488 ProLift Expandable SystemLife Spine, Inc. · 2019
- 1 generation backK212520 ProLift Micro Expandable Spacer SystemLife Spine, Inc. · 2021
- This deviceK250373 ProLift Expandable Spacer SystemLife Spine, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K133813 | Flxfit Intervertebral Body Fusion Device | Expanding Orthopedics, Inc. | 2014 | — |
| −4 | K153400 | ProLift Expandable System | Life Spine, Inc. | 2016 | — |
| −3 | K173182 | ProLift® Expandable System | Life Spine, Inc. | 2017 | — |
| −2 | K190488 | ProLift Expandable System | Life Spine, Inc. | 2019 | — |
| −1 | K212520 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | 2021 | — |
| 0 (this device) | K250373 | ProLift Expandable Spacer System | Life Spine, Inc. | 2025 | — |
| +1 | 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 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 11 | 0 |
| 2005 | 8 | 0 |
| 2006 | 3 | 0 |
| 2007 | 11 | 0 |
| 2008 | 24 | 0 |
| 2009 | 10 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K190488 | ProLift Expandable SystemSummary page 5…Intervertebral Body Fusion Device Classification: MAX, CFR 888.3080, Class II Primary Predicate: Life Spine ProLift Expandable Spacer System (K190488) Additional Predicate: Life Spine ProLift Micro (K212520, K223430) Device Description: The PROLIFT® Expandable Spacer Sy… | 2019 |
| * | K212520 | ProLift Micro Expandable Spacer SystemSummary page 5…MAX, CFR 888.3080, Class II Primary Predicate: Life Spine ProLift Expandable Spacer System (K190488) Additional Predicate: Life Spine ProLift Micro (K212520, K223430) Device Description: The PROLIFT® Expandable Spacer System is available in a range of sizes and footprints and can expa… | 2021 |
| * | K223430 | ProLift Micro Expandable Spacer SystemSummary page 5…R 888.3080, Class II Primary Predicate: Life Spine ProLift Expandable Spacer System (K190488) Additional Predicate: Life Spine ProLift Micro (K212520, K223430) Device Description: The PROLIFT® Expandable Spacer System is available in a range of sizes and footprints and can expand to the… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | 2026 | 0 |
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 41 years and passes through 12 companies; a new generation was cleared every 1.6 years on median.
- 19 of the 155 ancestors have a recall of any class.
- Of its descendants, K253748 (Life Spine, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K190488.
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. 2025, 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® Expandable 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 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® Expandable 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250373 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250373: ProLift 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/K250373
Report an extraction error
Are you the manufacturer?
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