510(k) · Cleared
ClearedE3D™-C Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evolution Spine · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jul 22, 2026 as substantially equivalent to K241846 (Evolution Spine, 2024) and 1 other predicate after a 30-day review. Its family tree reaches back 34 generations to 1984. 4 of the 1,380 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 22, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 34 generations to K841189 (1984). 1,379 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet. 4 of the 1,380 devices in this family, counting this one, have a Class I recall.
- Root · 34 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 30 generations between
- 3 generations backK240368 E3D™-A Interbody SystemEvolution Spine · 2024
- 2 generations backK241846 E3D™-C Interbody SystemEvolution Spine · 2024
- 1 generation backK260038 E3D™-C Interbody SystemEvolution Spine · 2026
- This deviceK262094 E3D™-C Interbody SystemEvolution Spine · 2026
Show all 34 generations
- Root · 34 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 33 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 32 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 31 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 30 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 29 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 28 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 27 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 26 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 25 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 24 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 23 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 22 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 21 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 20 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 19 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 18 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 17 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 16 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 15 generations backK160955 Tritanium® PL CageStryker · 2016
- 14 generations backK162262 Tritanium® PL CageStryker · 2016
- 13 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 12 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 11 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 10 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 9 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 8 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 7 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 6 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 5 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 4 generations backK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- 3 generations backK240368 E3D™-A Interbody SystemEvolution Spine · 2024
- 2 generations backK241846 E3D™-C Interbody SystemEvolution Spine · 2024
- 1 generation backK260038 E3D™-C Interbody SystemEvolution Spine · 2026
- This deviceK262094 E3D™-C Interbody SystemEvolution Spine · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −34 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −33 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −32 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −31 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −30 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −29 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −28 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −27 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −26 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −25 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −24 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −23 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −22 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −21 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −20 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −19 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −18 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −17 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −16 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −15 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −14 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −13 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −12 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −11 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −10 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −9 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −8 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −7 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −6 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −5 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| −4 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| −3 | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
| −2 | K241846 | E3D™-C Interbody System | Evolution Spine | 2024 | — |
| −1 | K260038 | E3D™-C Interbody System | Evolution Spine | 2026 | — |
| 0 (this device) | K262094 | E3D™-C Interbody System | Evolution Spine | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 4 | 0 |
| 1987 | 3 | 0 |
| 1988 | 3 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 2 | 0 |
| 1992 | 12 | 0 |
| 1993 | 10 | 0 |
| 1994 | 17 | 0 |
| 1995 | 25 | 0 |
| 1996 | 29 | 0 |
| 1997 | 22 | 0 |
| 1998 | 38 | 0 |
| 1999 | 31 | 0 |
| 2000 | 44 | 0 |
| 2001 | 55 | 0 |
| 2002 | 49 | 0 |
| 2003 | 59 | 0 |
| 2004 | 81 | 0 |
| 2005 | 68 | 0 |
| 2006 | 52 | 0 |
| 2007 | 46 | 0 |
| 2008 | 95 | 1 |
| 2009 | 68 | 0 |
| 2010 | 62 | 1 |
| 2011 | 79 | 0 |
| 2012 | 51 | 0 |
| 2013 | 54 | 0 |
| 2014 | 57 | 0 |
| 2015 | 54 | 1 |
| 2016 | 47 | 1 |
| 2017 | 42 | 0 |
| 2018 | 21 | 0 |
| 2019 | 16 | 0 |
| 2020 | 15 | 0 |
| 2021 | 8 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
4 devices in this family have a Class I recall. 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K241846 | E3D™-C Interbody SystemSummary page 5…n: 21 CFR §888.3080 Class: II Product Code: ODP, OVE Primary Predicate: E3D-C™ Interbody System (K241846, K260038) Reference Predicates: 4WEB Cervical Spine Truss System (K231739) Globus Coali… | 2024 |
| * | K260038 | E3D™-C Interbody SystemSummary page 5…21 CFR §888.3080 Class: II Product Code: ODP, OVE Primary Predicate: E3D-C™ Interbody System (K241846, K260038) Reference Predicates: 4WEB Cervical Spine Truss System (K231739) Globus Coalition AGX… | 2026 |
| † | K231739 | Cervical Spine Truss System (CSTS) | 2023 |
| † | K142218 | Coalition AGX Plate and Coalition AGX Spacer | 2015 |
| † | K212405 | EMERGE™ Anterior Cervical Plate System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 5 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 6 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 18 companies; a new generation was cleared every 8 months on median.
- 159 of the 1,379 ancestors have a recall of any class; 4 have a Class I recall.
- 4 other devices also cite its predicate K241846.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
E3D™-C Interbody System includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical degenerative disc disease (DDD), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc…
Read the full statement (188 words)
E3D™-C Interbody System includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical degenerative disc disease (DDD), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
E3D™-C Static Interbodies used without the E3D-C Integrated Plate, supplemental fixation must be used (e.g. cervical plates or cervical posterior fixation).
E3D™-C Integrated Interbodies are intended to be used with screws or anchors. When used with two screws, these devices are stand-alone interbody fusion devices. When used with anchors, or without screws, these devices are intended to be used with the integrated plate or supplemental fixation (e.g. cervical plates or cervical posterior fixation).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262094: E3D™-C Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262094
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026