510(k) · Cleared
ClearedTruLift Expandable 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 Jul 28, 2026 as substantially equivalent to K201721 (Life Spine, Inc., 2020) and 1 other predicate after an 89-day review. Its family tree reaches back 20 generations to 1984.
- Decided
- Jul 28, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K841189 (1984). 182 ancestors in all. No later device cites it as a predicate yet.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK190488 ProLift Expandable SystemLife Spine, Inc. · 2019
- 2 generations backK212520 ProLift Micro Expandable Spacer SystemLife Spine, Inc. · 2021
- 1 generation backK232611 TruLift Micro Expandable Spacer System & TruLift Expandable Spacer…Life Spine, Inc. · 2023
- This deviceK261430 TruLift Expandable SystemLife Spine, Inc. · 2026
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK133813 Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc. · 2014
- 5 generations backK153400 ProLift Expandable SystemLife Spine, Inc. · 2016
- 4 generations backK173182 ProLift® Expandable SystemLife Spine, Inc. · 2017
- 3 generations backK190488 ProLift Expandable SystemLife Spine, Inc. · 2019
- 2 generations backK212520 ProLift Micro Expandable Spacer SystemLife Spine, Inc. · 2021
- 1 generation backK232611 TruLift Micro Expandable Spacer System & TruLift Expandable Spacer…Life Spine, Inc. · 2023
- This deviceK261430 TruLift Expandable SystemLife Spine, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K133813 | Flxfit Intervertebral Body Fusion Device | Expanding Orthopedics, Inc. | 2014 | — |
| −5 | K153400 | ProLift Expandable System | Life Spine, Inc. | 2016 | — |
| −4 | K173182 | ProLift® Expandable System | Life Spine, Inc. | 2017 | — |
| −3 | K190488 | ProLift Expandable System | Life Spine, Inc. | 2019 | — |
| −2 | K212520 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | 2021 | — |
| −1 | K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | Life Spine, Inc. | 2023 | — |
| 0 (this device) | K261430 | TruLift Expandable System | 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 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 11 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 25 | 0 |
| 2009 | 14 | 0 |
| 2010 | 11 | 0 |
| 2011 | 10 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K201721 | TruLift Expandable Spacer SystemSummary page 5…Intervertebral Body Fusion Device Classification: MAX, CFR 888.3080, Class II Primary Predicate: Life Spine TruLift Expandable System (K201721) Additional Predicate: Life Spine TruLift Expandable System (K232611) Device Description: The TRULIFT® Expandable Space… | 2020 |
| * | K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemSummary page 5…X, CFR 888.3080, Class II Primary Predicate: Life Spine TruLift Expandable System (K201721) Additional Predicate: Life Spine TruLift Expandable System (K232611) Device Description: The TRULIFT® Expandable Spacer System is available in a range of sizes and footprints and can expand to t… | 2023 |
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 42 years and passes through 12 companies; a new generation was cleared every 1.6 years on median.
- 20 of the 182 ancestors have a recall of any class.
- 2 other devices also cite its predicate K201721.
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. 2026, 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 TRULIFT® 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 (143 words)
When used as an interbody fusion device, the TRULIFT® 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/K261430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261430: TruLift Expandable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261430
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026