510(k) · Cleared
ClearedProLift Lateral HELO Fixated
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 30, 2021 as substantially equivalent to K200338 (Life Spine, Inc., 2020) and 4 other predicates after a 109-day review. Its family tree reaches back 19 generations to 1984. 3 later devices descend from it.
- Decided
- Apr 30, 2021
- Review
- 109 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 19 generations to K841189 (1984). 354 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 2 generations backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- 1 generation backK200338 ProLift Lateral FixatedLife Spine, Inc. · 2020
- This deviceK210061 ProLift Lateral HELO FixatedLife Spine, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK221806 TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK251502 TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK223335 SIRION Lateral Lumbar Interbody SystemAstura Medical · 2023
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 backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 9 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 8 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 7 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 6 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 5 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 4 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 3 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 2 generations backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- 1 generation backK200338 ProLift Lateral FixatedLife Spine, Inc. · 2020
- This deviceK210061 ProLift Lateral HELO FixatedLife Spine, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022 · cites it directly1descendant
- K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc. · 2025 · cites it directly0descendants
- K223335SIRION Lateral Lumbar Interbody SystemAstura Medical · 2023 · 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 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −9 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −8 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −7 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −6 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −5 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −4 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −3 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −2 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| −1 | K200338 | ProLift Lateral Fixated | Life Spine, Inc. | 2020 | — |
| 0 (this device) | K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | 2021 | — |
| +1 | K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | 2022 | — |
| +1 | K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. | 2025 | — |
| +1 | K223335 | SIRION Lateral Lumbar Interbody System | Astura Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 14 | 0 |
| 2002 | 20 | 0 |
| 2003 | 25 | 0 |
| 2004 | 38 | 0 |
| 2005 | 25 | 0 |
| 2006 | 17 | 0 |
| 2007 | 17 | 0 |
| 2008 | 38 | 0 |
| 2009 | 24 | 0 |
| 2010 | 19 | 0 |
| 2011 | 20 | 0 |
| 2012 | 14 | 0 |
| 2013 | 18 | 0 |
| 2014 | 10 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K200338 | ProLift Lateral FixatedSummary page 4…tion: MAX, CFR 888.3080, Class II OVD, CFR 888.3080, Class II Primary Predicate: Life Spine ProLift Lateral Fixated (K200338) Additional Predicate: Life Spine TruLift Expandable Cage (K201721) Life Spine ProLift Expan… | 2020 |
| * | K201721 | TruLift Expandable Spacer SystemSummary page 4…OVD, CFR 888.3080, Class II Primary Predicate: Life Spine ProLift Lateral Fixated (K200338) Additional Predicate: Life Spine TruLift Expandable Cage (K201721) Life Spine ProLift Expandable System (Kl73182) Globus Elsa Spacer (K16… | 2020 |
| * | K173182 | ProLift® Expandable SystemSummary page 5…ng to ASTM F2077, was presented to demonstrated that the ProLift® Lateral HELO Fixated is safe, effective and substantially equivalent to the Pro-Lift Expandable System (K173182). Substantial Equivalence: The ProLift Lateral HELO Fixated was shown to be substantially equivalent to the predicate devices in… | 2017 |
| * | K161379 | ELSA SpacersSummary page 4…Life Spine TruLift Expandable Cage (K201721) Life Spine ProLift Expandable System (Kl73182) Globus Elsa Spacer (K161379) Life Spine Plateau Spacer System (K08041 1) Device Description: The ProLift® Lateral HELO Fixated… | 2016 |
| * | K080411 | Plateau Spacer SystemSummary page 4…Life Spine ProLift Expandable System (Kl73182) Globus Elsa Spacer (K161379) Life Spine Plateau Spacer System (K08041 1) Device Description: The ProLift® Lateral HELO Fixated is intended to serve as an intervertebral body fusion device. The implan… | 2008 |
What descends from it? (3)
3 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 37 years and passes through 15 companies; a new generation was cleared every 1.0 years on median.
- 29 of the 354 ancestors have a recall of any class.
- Of its descendants, K221806 (Life Spine, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K200338.
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. 2021, 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 Lateral HELO Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up…
Read the full statement (130 words)
The ProLift Lateral HELO Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The ProLift Lateral HELO Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The ProLift Lateral HELO Fixated must be used with FDA cleared supplemental fixation. The ProLift Lateral HELO Fixated may optionally be used with two bone screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210061: ProLift Lateral HELO Fixated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210061
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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