# K260036: NeckTune™ 3D SA Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey Co, Ltd.
- Decided: Jun 15, 2026 after 160 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: 33 generations back to K841189 (1984). 1,387 ancestors in all.
No later device cites it as a predicate yet.
4 of 1,388 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190546: NEXXT MATRIXX Stand Alone Cervical System, Nexxt Spine, LLC (2019) Summary page 5.
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System, Nexxt Spine, LLC (2020) Summary page 5.
- K232348: RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System, MiRus, LLC (2023) Summary page 5.
- K241846: E3D™-C Interbody System, Evolution Spine (2024) Summary page 5.

## Indications for use
The NeckTune™ 3D SA Cervical Cage is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with associated radicular symptoms at one or two contiguous disc levels from C2-C3 through C7-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The NeckTune™ 3D SA Cervical Cage is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. The cage is intended to be used with the two provided fixation screws and, when used as intended, functions as a stand-alone interbody fusion device. For cages with a lordotic angle of 20° or greater, use in the cervical spine requires combination with an FDA-cleared supplemental fixation system (e.g., cervical plates or cervical posterior fixation). If the physician chooses to use the cage with fewer than two (2) screws, an FDA-cleared supplemental fixation system must be used. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K260036
Methodology: https://510kreport.com/methodology