# K241846: E3D™-C Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Evolution Spine
- Decided: Aug 12, 2024 after 47 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 32 generations back to K841189 (1984). 1,377 ancestors in all.
6 later devices descend from it; 5 cite it directly.
4 of 1,384 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments, Globus Medical, Inc. (2022) Summary page 5.
- K151939: COALITION Spacers, Globus Medical, Inc. (2016) Summary page 5.
- K191477: AEON-C Stand Alone System, Huvexel Co., Ltd. (2019) Summary page 5.
- K223146: EVOLUTION SPINE Interbody System, Evolution Spine (2023) Summary page 5.
- K232432: E3D™-A Interbody System, Evolution Spine (2024) Summary page 5.
- K240368: E3D™-A Interbody System, Evolution Spine (2024) Summary page 5.

## Most influential descendants
- K260038: E3D™-C Interbody System (2026), 1 descendant of its own
- K252894: aprevo® cervical interbody system (2026), 1 descendant of its own
- K262094: E3D™-C Interbody System (2026), 0 descendants of its own
- K260036: NeckTune™ 3D SA Cervical Cage (2026), 0 descendants of its own
- K260385: aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (2026), 0 descendants of its own

## Indications for use
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 are intended to be used with supplemental fixation (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 supplemental fixation (e.g. cervical plates or cervical posterior fixation).

Source page: https://510kreport.com/device/K241846
Methodology: https://510kreport.com/methodology