# K231251: FlexWing Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Jul 24, 2024 after 450 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K953730 (1995). 61 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192314: RESONATE Anterior Cervical Plate System, Globus Medical, Inc. (2019) Summary page 4.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 4.
- K140234: Aspiron Acp System, U&I Corp. (2014) Summary page 6.

## Most influential descendants
- K252826: ARIX Femur Nail System (2025), 0 descendants of its own
- K251431: FIX-C PEEK ACIF SA System (2025), 0 descendants of its own

## Indications for use
The FlexWing Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine(C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

Source page: https://510kreport.com/device/K231251
Methodology: https://510kreport.com/methodology