510(k) · Cleared
ClearedProLift Pivot 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 Jan 23, 2025 as substantially equivalent to K190488 (Life Spine, Inc., 2019) and 5 other predicates after a 57-day review. Its family tree reaches back 22 generations to 1984.
- Decided
- Jan 23, 2025
- Review
- 57 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 22 generations to K841189 (1984). 218 ancestors in all. No later device cites it as a predicate yet.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK170235 Lucent®Spinal Elements, Inc. · 2017
- 2 generations backK182584 Lucent® XPSpinal Elements, Inc. · 2018
- 1 generation backK202298 Lucent XP, Lucent XP CurvedSpinal Elements, Inc. · 2020
- This deviceK243668 ProLift Pivot Expandable Spacer SystemLife Spine, Inc. · 2025
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 4 generations backK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
- 3 generations backK170235 Lucent®Spinal Elements, Inc. · 2017
- 2 generations backK182584 Lucent® XPSpinal Elements, Inc. · 2018
- 1 generation backK202298 Lucent XP, Lucent XP CurvedSpinal Elements, Inc. · 2020
- This deviceK243668 ProLift Pivot Expandable Spacer SystemLife Spine, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| −4 | K162327 | COUGAR® LS Lateral Cage System and COUGAR® System | Medos International SARL | 2016 | — |
| −3 | K170235 | Lucent® | Spinal Elements, Inc. | 2017 | — |
| −2 | K182584 | Lucent® XP | Spinal Elements, Inc. | 2018 | — |
| −1 | K202298 | Lucent XP, Lucent XP Curved | Spinal Elements, Inc. | 2020 | — |
| 0 (this device) | K243668 | ProLift Pivot Expandable Spacer System | Life Spine, Inc. | 2025 | — |
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 | 14 | 0 |
| 2004 | 18 | 0 |
| 2005 | 13 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 30 | 0 |
| 2009 | 16 | 0 |
| 2010 | 13 | 0 |
| 2011 | 15 | 0 |
| 2012 | 9 | 0 |
| 2013 | 10 | 0 |
| 2014 | 9 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | 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: Spinal Elements Lucent Xp Curved (K202298) Globus Altera Spacer (K140411)… | 2019 |
| * | K202298 | Lucent XP, Lucent XP CurvedSummary page 5…X, CFR 888.3080, Class II Primary Predicate: Life Spine ProLift Expandable Spacer System (K190488) Additional Predicate: Spinal Elements Lucent Xp Curved (K202298) Globus Altera Spacer (K140411) Life Spine ProLift Micro (K212520, K223430)… | 2020 |
| * | K140411 | Altera SpacerSummary page 5…Spine ProLift Expandable Spacer System (K190488) Additional Predicate: Spinal Elements Lucent Xp Curved (K202298) Globus Altera Spacer (K140411) Life Spine ProLift Micro (K212520, K223430) Life Spine Steerable Plateau T… | 2014 |
| * | K212520 | ProLift Micro Expandable Spacer SystemSummary page 5…Predicate: Spinal Elements Lucent Xp Curved (K202298) Globus Altera Spacer (K140411) Life Spine ProLift Micro (K212520, K223430) Life Spine Steerable Plateau Ti (K193521) Device Description: The ProLift® Pivot Expandable… | 2021 |
| * | K223430 | ProLift Micro Expandable Spacer SystemSummary page 5…: Spinal Elements Lucent Xp Curved (K202298) Globus Altera Spacer (K140411) Life Spine ProLift Micro (K212520, K223430) Life Spine Steerable Plateau Ti (K193521) Device Description: The ProLift® Pivot Expandable System i… | 2023 |
| * | K193521 | Steerable Plateau TiSummary page 5…Globus Altera Spacer (K140411) Life Spine ProLift Micro (K212520, K223430) Life Spine Steerable Plateau Ti (K193521) Device Description: The ProLift® Pivot Expandable System is available in a range of sizes and footprints and can expand to the… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 companies; a new generation was cleared every 1.0 years on median.
- 23 of the 218 ancestors have a recall of any class.
- 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?
The Prolift Pivot Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels (L2-S1 ). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DOD 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…
Read the full statement (138 words)
The Prolift Pivot Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels (L2-S1 ). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DOD 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/K243668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243668: ProLift Pivot Expandable 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/K243668
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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