# K262726: NeckTune™ SA Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey Co., Ltd.
- Decided: Sep 29, 2026 after 60 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: 18 generations back to K003155 (2001). 143 ancestors in all.
No later device cites it as a predicate yet.
1 of 144 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210573: Velofix SA Cervical Cage, U&I Corporation (2021) Summary page 5.

## Cited in the summary but kept off the family tree
- K260060: NeckTune™ 3D SA Cervical Cage. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K231340: Renova Spine Balloon Catheter, Biopsybell S.R.L. (2023). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The NeckTune™ 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™ 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 a legally marketed 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, a legally marketed 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/K262726
Methodology: https://510kreport.com/methodology