510(k) · Cleared
ClearedProLift Lateral Fixated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Apr 17, 2020 as substantially equivalent to K191005 (Life Spine, Inc., 2019) and 3 other predicates after a 66-day review. Its family tree reaches back 18 generations to 1984. 5 later devices descend from it.
- Decided
- Apr 17, 2020
- Review
- 66 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K841189 (1984). 335 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 3 citing it directly.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- This deviceK200338 ProLift Lateral FixatedLife Spine, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK210061 ProLift Lateral HELO FixatedLife Spine, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK221806 TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK253748 Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated…Life Spine, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251502 TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK223335 SIRION Lateral Lumbar Interbody SystemAstura Medical · 2023
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 8 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 7 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 6 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 5 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 4 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- This deviceK200338 ProLift Lateral FixatedLife Spine, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K210061ProLift Lateral HELO FixatedLife Spine, Inc. · 2021 · cites it directly3descendants
- K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022 · 2 generations on1descendant
- K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc. · 2026 · cites it directly0descendants
- K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc. · 2025 · cites it directly0descendants
- K223335SIRION Lateral Lumbar Interbody SystemAstura Medical · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −8 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −7 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −6 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −5 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −4 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −3 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −2 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −1 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| 0 (this device) | K200338 | ProLift Lateral Fixated | Life Spine, Inc. | 2020 | — |
| +1 | K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | 2021 | — |
| +2 | K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | 2022 | — |
| +1 | K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable… | Life Spine, Inc. | 2026 | — |
| +1 | K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. | 2025 | — |
| +2 | 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 | 15 | 0 |
| 2007 | 17 | 0 |
| 2008 | 37 | 0 |
| 2009 | 20 | 0 |
| 2010 | 17 | 0 |
| 2011 | 19 | 0 |
| 2012 | 11 | 0 |
| 2013 | 16 | 0 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191005 | ProLift® Expandable SystemSummary page 4…ication: OVD, CFR 888.3080, Class II MAX, CFR 888.3080, Class II Primary Predicate: Life Spine ProLift Expandable System (K191005) Additional Predicate: Life Spine ProLift Expandable System (K173182) Globus Elsa (K161379)… | 2019 |
| * | K173182 | ProLift® Expandable SystemSummary page 4…MAX, CFR 888.3080, Class II Primary Predicate: Life Spine ProLift Expandable System (K191005) Additional Predicate: Life Spine ProLift Expandable System (K173182) Globus Elsa (K161379) Life Spine Sentry (K180166) Device Description: Th… | 2017 |
| * | K161379 | ELSA SpacersSummary page 4…Life Spine ProLift Expandable System (K191005) Additional Predicate: Life Spine ProLift Expandable System (K173182) Globus Elsa (K161379) Life Spine Sentry (K180166) Device Description: The ProLift® Lateral Fixated is intended to serve a… | 2016 |
| * | K180166 | Life Spine Lumbar Fixation System (SENTRY)Summary page 4…Additional Predicate: Life Spine ProLift Expandable System (K173182) Globus Elsa (K161379) Life Spine Sentry (K180166) Device Description: The ProLift® Lateral Fixated is intended to serve as an intervertebral body fusion device. The implant is… | 2018 |
What descends from it? (5)
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 36 years and passes through 15 companies; a new generation was cleared every 1.0 years on median.
- 29 of the 335 ancestors have a recall of any class.
- Of its descendants, K210061 (Life Spine, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K191005.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The ProLift® Lateral 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…
Read the full statement (117 words)
The ProLift® Lateral 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 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift® Lateral Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200338: ProLift Lateral Fixated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200338
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