510(k) · Cleared
ClearedE3D™-A Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evolution Spine · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on May 15, 2024 as substantially equivalent to K223146 (Evolution Spine, 2023) and 3 other predicates after a 99-day review. Its family tree reaches back 31 generations to 1984. 2 of the 1,201 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- May 15, 2024
- Review
- 99 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 31 generations to K841189 (1984). 1,193 ancestors in all, the oldest K761228 (1976). 7 later devices descend from it, 1 citing it directly. 2 of the 1,201 devices in this family, counting this one, have a Class I recall.
- Root · 31 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 27 generations between
- 3 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 2 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 1 generation backK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- This deviceK240368 E3D™-A Interbody SystemEvolution Spine · 2024
- Descendant · cites it directly · 6 of its ownK241846 E3D™-C Interbody SystemEvolution Spine · 2024
- Descendant · 2 generations on · 1 of its ownK260038 E3D™-C Interbody SystemEvolution Spine · 2026
- Descendant · 2 generations on · 1 of its ownK252894 aprevo® cervical interbody systemCarlsmed, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK262094 E3D™-C Interbody SystemEvolution Spine · 2026
- Descendant · 2 generations on · 0 of its ownK260036 NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd. · 2026
Show all 31 generations
- Root · 31 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 30 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 29 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 28 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 27 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 26 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 25 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 24 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 23 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 22 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 21 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 20 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 19 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 18 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 17 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 16 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 15 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 14 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 13 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 12 generations backK160955 Tritanium® PL CageStryker · 2016
- 11 generations backK162262 Tritanium® PL CageStryker · 2016
- 10 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 9 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 8 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 7 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 6 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 5 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 4 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 3 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 2 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 1 generation backK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- This deviceK240368 E3D™-A Interbody SystemEvolution Spine · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K241846E3D™-C Interbody SystemEvolution Spine · 2024 · cites it directly6descendants
- K260038E3D™-C Interbody SystemEvolution Spine · 2026 · 2 generations on1descendant
- K252894aprevo® cervical interbody systemCarlsmed, Inc. · 2026 · 2 generations on1descendant
- K262094E3D™-C Interbody SystemEvolution Spine · 2026 · 2 generations on0descendants
- K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −31 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −30 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −29 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −28 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −27 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −26 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −25 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −24 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −23 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −22 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −21 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −20 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −19 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −18 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −17 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −16 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −15 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −14 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −13 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −12 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −11 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −10 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −9 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −8 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −7 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −6 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −5 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −4 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −3 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −2 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| −1 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| 0 (this device) | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
| +1 | K241846 | E3D™-C Interbody System | Evolution Spine | 2024 | — |
| +2 | K260038 | E3D™-C Interbody System | Evolution Spine | 2026 | — |
| +2 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | — |
| +2 | K262094 | E3D™-C Interbody System | Evolution Spine | 2026 | — |
| +2 | K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 4 | 0 |
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 11 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 21 | 0 |
| 1996 | 23 | 0 |
| 1997 | 21 | 0 |
| 1998 | 34 | 0 |
| 1999 | 24 | 0 |
| 2000 | 35 | 0 |
| 2001 | 45 | 0 |
| 2002 | 42 | 0 |
| 2003 | 53 | 0 |
| 2004 | 68 | 0 |
| 2005 | 57 | 0 |
| 2006 | 42 | 0 |
| 2007 | 42 | 0 |
| 2008 | 85 | 1 |
| 2009 | 62 | 0 |
| 2010 | 56 | 1 |
| 2011 | 70 | 0 |
| 2012 | 46 | 0 |
| 2013 | 51 | 0 |
| 2014 | 51 | 0 |
| 2015 | 45 | 0 |
| 2016 | 40 | 0 |
| 2017 | 35 | 0 |
| 2018 | 20 | 0 |
| 2019 | 13 | 0 |
| 2020 | 13 | 0 |
| 2021 | 7 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 6 | 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.
2 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 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 |
|---|---|---|---|
| * | K223146 | EVOLUTION SPINE Interbody SystemSummary page 5…21 CFR §888.3080 Class: II Product Code: OVD, MAX, PHM Primary Predicate: EVOLUTION SPINE Interbody System (K223146) Additional Predicates: E3D™-A Interbody System (K232432) Globus Hedron IA (K191391)… | 2023 |
| * | K232432 | E3D™-A Interbody SystemSummary page 5…ode: OVD, MAX, PHM Primary Predicate: EVOLUTION SPINE Interbody System (K223146) Additional Predicates: E3D™-A Interbody System (K232432) Globus Hedron IA (K191391) Alphatec Spine - IdentiTi™ NanoTec™ A… | 2024 |
| * | K191391 | HEDRON Lumbar SpacersSummary page 5…EVOLUTION SPINE Interbody System (K223146) Additional Predicates: E3D™-A Interbody System (K232432) Globus Hedron IA (K191391) Alphatec Spine - IdentiTi™ NanoTec™ ALIF Standalone Interbody Sy… | 2019 |
| * | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Summary page 5…Globus Hedron IA (K191391) Alphatec Spine - IdentiTi™ NanoTec™ ALIF Standalone Interbody System (K222028) Device Description: The E3D™-A Interbody System provides interbody fusion devices designed to provide structural stability dur… | 2022 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241846 | E3D™-C Interbody System | 2024 | 6 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 40 years and passes through 18 companies; a new generation was cleared every 8 months on median.
- 126 of the 1,193 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K241846 (Evolution Spine, 2024) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K223146.
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. 2024, 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?
E3D™-A Static Interbody Devices are thoraco-lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed…
Read the full statement (393 words)
E3D™-A Static Interbody Devices are thoraco-lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.
E3D ™-A Integrated Interbody Devices are integrated lumbar interbody fusion devices 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). Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). Hyperlordotic implants (>20° lordosis) are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation).
When used for multilevel degenerative scoliosis or sagittal deformity, supplemental fixation that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) must be used.
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/K240368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240368: E3D™-A 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/K240368
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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