# K251431: FIX-C PEEK ACIF SA System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Jun 27, 2025 after 50 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: 26 generations back to K841189 (1984). 584 ancestors in all.
No later device cites it as a predicate yet.
1 of 585 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192502: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus, Medtronic Sofamor Danek USA, Inc. (2020) Summary page 5.
- K212266: FIX-C PEEK Anterior Cervical Interbody System, Jeil Medical Corporation (2021) Summary page 5.
- K231251: FlexWing Anterior Cervical Plate System, Jeil Medical Corporation (2024) Summary page 5.

## Indications for use
The FIX-C PEEK ACIF SA System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. 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. The stand-alone interbody cages must be used with internal screw fixation. The FIX-C PEEK ACIF SA System is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K251431
Methodology: https://510kreport.com/methodology