510(k) · Cleared
ClearedStandalone ALIF Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eminent Spine · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Oct 17, 2022 as substantially equivalent to K191391 (Globus Medical, Inc., 2019) after a 108-day review. Its family tree reaches back 22 generations to 1984. 2 later devices descend from it.
- Decided
- Oct 17, 2022
- Review
- 108 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 22 generations to K841189 (1984). 293 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- 1 generation backK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- This deviceK221936 Standalone ALIF Interbody Fusion SystemEminent Spine · 2022
- Descendant · cites it directly · 0 of its ownK253260 ORIO-3D Cage SystemSpineCraft · 2026
- Descendant · cites it directly · 0 of its ownK230851 Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 2023
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 backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 4 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- 1 generation backK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- This deviceK221936 Standalone ALIF Interbody Fusion SystemEminent Spine · 2022
Most influential descendants
Showing 2 of 2 · See allView 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 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −4 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
| −1 | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | — |
| 0 (this device) | K221936 | Standalone ALIF Interbody Fusion System | Eminent Spine | 2022 | — |
| +1 | K253260 | ORIO-3D Cage System | SpineCraft | 2026 | — |
| +1 | K230851 | Kodiak Lumbar Spacer System | Met One Technologies, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 17 | 0 |
| 2004 | 27 | 0 |
| 2005 | 17 | 0 |
| 2006 | 12 | 0 |
| 2007 | 15 | 0 |
| 2008 | 36 | 0 |
| 2009 | 22 | 0 |
| 2010 | 18 | 0 |
| 2011 | 18 | 0 |
| 2012 | 15 | 0 |
| 2013 | 18 | 0 |
| 2014 | 11 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K191391 | HEDRON Lumbar SpacersSummary page 4…ation: Class II Reviewing Panel: Orthopedic Product Code: OVD Primary Predicate Device: Globus HEDRON Lumbar Spacers (K191391) The primary predicate device has never been subject to a recall. Reference Predicate Device:… | 2019 |
| † | K212853 | Cervical Stand-Alone System | 2021 |
What descends from it? (2)
2 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 38 years and passes through 14 companies; a new generation was cleared every 11 months on median.
- 30 of the 293 ancestors have a recall of any class.
- Of its descendants, K253260 (SpineCraft, 2026) has gone furthest, with 0 descendants of its own.
- 18 other devices also cite its predicate K191391.
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. 2022, 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 Eminent Spine Standalone ALIF Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The Eminent Spine Standalone ALIF Interbody Fusion System is a stand-alone interbody fusion device intended to be used with screws which accompany the spacers for fixation. Hyperlordotic implants (2:25 ° lordosis) are intended for use…
Read the full statement (165 words)
The Eminent Spine Standalone ALIF Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The Eminent Spine Standalone ALIF Interbody Fusion System is a stand-alone interbody fusion device intended to be used with screws which accompany the spacers for fixation. Hyperlordotic implants (2:25 ° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I Spondylolisthesis or retrolisthesis. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221936 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221936: Standalone ALIF Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221936
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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