510(k) · Cleared
ClearedEminent Spine 3D Lumbar Interbody Fusion Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eminent Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 16, 2023 as substantially equivalent to K090064 (Eminent Spine, 2009) and 2 other predicates after a 110-day review. Its family tree reaches back 9 generations to 1984. 4 later devices descend from it.
- Decided
- May 16, 2023
- Review
- 110 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K841189 (1984). 34 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 2 generations backK090064 Eminent Spine Interbody Fusion SystemEminent Spine · 2009 · Recalled
- 1 generation backK212701 Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine · 2023
- This deviceK230219 Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC · 2023
- Descendant · cites it directly · 2 of its ownK243074 Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253260 ORIO-3D Cage SystemSpineCraft · 2026
- Descendant · 2 generations on · 0 of its ownK252240 Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026
- Descendant · 2 generations on · 0 of its ownK253377 Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 3 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 2 generations backK090064 Eminent Spine Interbody Fusion SystemEminent Spine · 2009 · Recalled
- 1 generation backK212701 Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine · 2023
- This deviceK230219 Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC · 2023
Most influential descendants
Showing 4 of 4 · See all- K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025 · cites it directly2descendants
- K253260ORIO-3D Cage SystemSpineCraft · 2026 · cites it directly0descendants
- K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026 · 2 generations on0descendants
- K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −3 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −2 | K090064 | Eminent Spine Interbody Fusion System | Eminent Spine | 2009 | 1 |
| −1 | K212701 | Eminent Spine 3D Cervical Interbody Fusion System | Eminent Spine | 2023 | — |
| 0 (this device) | K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | Eminent Spine, LLC | 2023 | — |
| +1 | K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025 | — |
| +1 | K253260 | ORIO-3D Cage System | SpineCraft | 2026 | — |
| +2 | K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026 | — |
| +2 | K253377 | Expandable Titanium PLIF/TLIF System | Spectrum 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 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 4…fication: Class II Reviewing Panel: Orthopedic Product Code: MAX Primary Predicate Device: Eminent Spine Interbody Fusion System (K090064) Additional Predicate Devices: Eminent Spine 3D Cervical Interbody Fusion System (K212701) Cancelle… | 2009 |
| * | K212701 | Eminent Spine 3D Cervical Interbody Fusion System Cleared while this submission was under review Summary page 4…MAX Primary Predicate Device: Eminent Spine Interbody Fusion System (K090064) Additional Predicate Devices: Eminent Spine 3D Cervical Interbody Fusion System (K212701) CancelleX Porous Titanium Lumbar Interbody Device (K190364) Device Description: The Eminent Spin… | 2023 |
| * | K190364 | CancelleX Porous Titanium Lumbar Interbody DeviceSummary page 4…dditional Predicate Devices: Eminent Spine 3D Cervical Interbody Fusion System (K212701) CancelleX Porous Titanium Lumbar Interbody Device (K190364) Device Description: The Eminent Spine 3D Lumbar Interbody Fusion Systems are intervertebral body fusion systems used in the sp… | 2019 |
What descends from it? (4)
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 39 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 34 ancestors have a recall of any class.
- Of its descendants, K243074 (Spectrum Spine, Inc., 2025) has gone furthest, with 2 descendants of its own.
- 33 other devices also cite its predicate K090064.
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. 2023, 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 Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are 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 device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin…
Read the full statement (115 words)
The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are 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 device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230219 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230219: Eminent Spine 3D Lumbar Interbody Fusion Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230219
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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