# K243915: FIX-C 3D Ti ACIF System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Feb 18, 2025 after 60 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 26 generations back to K841189 (1984). 465 ancestors in all.
No later device cites it as a predicate yet.
1 of 466 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233839: Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system, Gbs Commonwealth Co., Ltd. (2023) Summary page 5.
- K241738: PYXIS 3D Titanium Cervical Cage system, GS Medical Co., Ltd. (2024) Summary page 5.
- K212266: FIX-C PEEK Anterior Cervical Interbody System, Jeil Medical Corporation (2021) Summary page 5.

## Indications for use
The FIX-C 3D Ti ACIF System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1. The FIX-C 3D Ti ACIF System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The FIX-C 3D Ti ACIF System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Source page: https://510kreport.com/device/K243915
Methodology: https://510kreport.com/methodology