510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Eminent Spine Interbody Fusion System

K090064510(k) TraditionalCleared Apr 9, 200990-day reviewClass II21 CFR 888.3080Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eminent Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Apr 9, 2009 as substantially equivalent to P970015 (Sofamor Danek, 1999) and 8 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1984. 701 later devices descend from it. It has been recalled once.

Decided
Apr 9, 2009
Review
90 days
Class
Class II
Product code
MAX
Recalls
1
Predicates
9

Its longest line of descent runs back 7 generations to K841189 (1984). 31 ancestors in all. 701 later devices descend from it, 34 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors2002: 4 other ancestors2001: 8 other ancestors1999: 2 other ancestors1996: 2 other ancestors2005: 1 other ancestor2004: 3 other ancestors2003: 1 other ancestor2000: 1 other ancestor2013: 13 descendants cleared2019: 51 descendants cleared2015: 10 descendants cleared2023: 89 descendants cleared2017: 42 descendants cleared2016: 16 descendants cleared2012: 5 descendants cleared2011: 2 descendants cleared2010: 1 descendant cleared2018: 47 descendants cleared2014: 18 descendants cleared2020: 68 descendants cleared2026: 62 descendants cleared2024: 82 descendants cleared2021: 59 descendants cleared2025: 68 descendants cleared2022: 68 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K043479 · MC+ Partial VBR · Ldr Spine USA · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 3 other ancestors3 generations back: 4 other ancestors4 generations back: 7 other ancestors5 generations back: 2 other ancestors 1 generation forward: 34 descendants2 generations forward: 54 descendants3 generations forward: 66 descendants4 generations forward: 98 descendants5 generations forward: 137 descendants6 generations forward: 131 descendants7 generations forward: 102 descendants8 generations forward: 57 descendants9 generations forward: 17 descendants10 generations forward: 3 descendants11 generations forward: 2 descendants K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−50+5+10
  1. Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 2 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  7. 1 generation backK043479 MC+ Partial VBRLdr Spine USA · 2005
  8. This deviceK090064 Eminent Spine Interbody Fusion SystemEminent Spine · 2009
  9. Descendant · cites it directly · 462 of its ownK131372 Mobis IISignus Medizintechnik GmbH · 2013
  10. Descendant · 2 generations on · 461 of its ownK141405 Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014
  11. Descendant · 3 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
  12. Descendant · cites it directly · 454 of its ownK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
  13. Descendant · 2 generations on · 453 of its ownK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014

Showing 5 of 701 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22012: 52013: 132014: 182015: 102016: 162017: 422018: 472019: 512020: 682021: 592022: 682023: 892024: 822025: 682026: 62
2010high 89 (2023) · low 1 (2010)2026

Most influential descendants

Showing 5 of 701 · See all
  • K131372Mobis IISignus Medizintechnik GmbH · 2013 · cites it directly462descendants
  • K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014 · 2 generations on461descendants
  • K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 3 generations on459descendants
  • K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013 · cites it directly454descendants
  • K140003Coroent Small Interbody SystemNuvasive, Inc. · 2014 · 2 generations on453descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−6K990148Stackable Cage SystemDepuy Motech Acromed1999—
−5K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−4K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−3K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−2K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
−1K043479MC+ Partial VBRLdr Spine USA2005—
0 (this device)K090064Eminent Spine Interbody Fusion SystemEminent Spine2009—
+1K131372Mobis IISignus Medizintechnik GmbH2013—
+2K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014—
+3K150481Cascadia Interbody SystemK2m, Inc.20153
+1K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013—
+2K140003Coroent Small Interbody SystemNuvasive, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200180
200240
200310
200430
200510
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201250
2013130
2014180
2015100
2016160
2017420
2018470
2019510
2020680
2021590
2022680
2023890
2024820
2025680
2026620
FIG. 1 — Lineage of K090064, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*P970015Inter Fix Threaded Fusion Device
Summary page 1
…s, as well as various cleared interbody fusionNBR systems: - LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03) - BAK® Cage (P950…
Sofamor Danek19991
*P950002Bak Interbody Fusion System
Summary page 1
…® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03) - BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03) - RAY® Threaded Fusion Cage (P950019, Stryker, Approved…
Zimmer Spine, Inc.1996—
*P950019Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation
Summary page 1
…ek, Approved 9/10/03) - BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03) - RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03) - Lumbar I/F Cage (P960025, DePuy,…
Stryker Spine19961
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…- RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03) - Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) - BAK/C (P980048, Zimmer Spine, Approved 4/20/01)…
Depuy Spine, Inc.1999—
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 1
…9/4/03) - Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) - BAK/C (P980048, Zimmer Spine, Approved 4/20/01) - Affinity Cage System (P000028, Medtronic, Approved 6/13/02)…
Sulzer Spine-Tech2001—
*P000028Affinity (TM) Cage System
Summary page 1
…0025, DePuy, Approved 3/4/05) - BAK/C (P980048, Zimmer Spine, Approved 4/20/01) - Affinity Cage System (P000028, Medtronic, Approved 6/13/02) - Zeus Cages (K081614, Interbody Innovations, Cleared 9/5/08)…
Medtronic Sofamor Danek USA, Inc.2002—
*K081614Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages
Summary page 1
…er Spine, Approved 4/20/01) - Affinity Cage System (P000028, Medtronic, Approved 6/13/02) - Zeus Cages (K081614, Interbody Innovations, Cleared 9/5/08) - MC+ Partial VBR (K043479, LDR Spine, Cleared 6/30/05)…
Interbody Innovations, Llp2008—
*K043479MC+ Partial VBR
Summary page 1
…nic, Approved 6/13/02) - Zeus Cages (K081614, Interbody Innovations, Cleared 9/5/08) - MC+ Partial VBR (K043479, LDR Spine, Cleared 6/30/05) - Crystal (K073351, Spinal Elements, Inc., Cleared 1/24/08) === Pa…
Ldr Spine USA2005—
*K073351Crystal
Summary page 1
…terbody Innovations, Cleared 9/5/08) - MC+ Partial VBR (K043479, LDR Spine, Cleared 6/30/05) - Crystal (K073351, Spinal Elements, Inc., Cleared 1/24/08)…
Spinal Elements, Inc.2008—

Also cleared against P970015: 18 other devices →

What descends from it? (701)

See all 701

34 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131372Mobis IISignus Medizintechnik GmbH2013462
K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454
K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193
K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190
K103034Genesys Spine Interbody Fusion SystemGenesys Spine2010137
K150847Foundation Interbody DevicesCorelink, LLC201529
K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220
K123969XiphosDifusion Technologies201314
K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512
K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 20, 2013Class IIZ-1417-2013Labeling designThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
  • 5 of the 31 ancestors have a recall of any class.
  • Of its descendants, K131372 (Signus Medizintechnik GmbH, 2013) has gone furthest, with 462 descendants of its own.
  • 18 other devices also cite its predicate P970015.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

Intervertebral Body Fusion Device: The Eminent Spine Interbody Fusion System (Sidewinder, Python, and Cottonmouth) is indicated for intervertebral body fusion of the lumbar spine, from L2 to Si, 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…

Read the full statement (291 words)

Intervertebral Body Fusion Device:

The Eminent Spine Interbody Fusion System (Sidewinder, Python, and Cottonmouth) is indicated for intervertebral body fusion of the lumbar spine, from L2 to Si, 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 with autograft to facilitate fusion.

The Eminent Spine Interbody Fusion System (Copperhead) is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Vertebral Body Replacement Device:

The Eminent Spine System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Eminent Spine System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

Indications for use as stated in the FDA summary.

Also cleared against P970015

18 other devices cite the same predicate.

  • K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
  • K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017
  • K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
  • K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012
  • K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA · 2011
  • K103034Genesys Spine Interbody Fusion SystemGenesys Spine · 20101 recall

More from Eminent Spine

11 FDA decisions under this applicant name. See the company

  • K250894Eminent Spine Posterior SI SystemEminent Spine · 2025
  • K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine · 2025
  • K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine · 2024
  • K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine · 2023
  • K221936Standalone ALIF Interbody Fusion SystemEminent Spine · 2022

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K090064 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090064: Eminent Spine Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090064

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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