# K191477: AEON-C Stand Alone System

- Pathway: 510(k) (Traditional)
- Applicant: Huvexel Co., Ltd.
- Decided: Nov 13, 2019 after 162 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: 21 generations back to K841189 (1984). 344 ancestors in all.
10 later devices descend from it; 2 cite it directly.
1 of 355 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 5.
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS, Globus Medical, Inc. (2017) Summary page 5.
- K122771: Spinal Elements Cervical Intervertebral Body Fusion System, Spinal Elements, Inc. (2013) Summary page 5.
- K181837: Spinal Elements Ti-Bond coated devices, Spinal Elements, Inc. (2018) Summary page 5.
- K160125: Cascadia Interbody System, K2m (2016) Summary page 5.

## Most influential descendants
- K241846: E3D™-C Interbody System (2024), 6 descendants of its own
- K223140: AEON-C™ Stand Alone System (2022), 2 descendants of its own
- K260038: E3D™-C Interbody System (2026), 1 descendant of its own
- K252894: aprevo® cervical interbody system (2026), 1 descendant of its own
- K232877: FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System (2023), 1 descendant of its own

## Indications for use
The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device.

Source page: https://510kreport.com/device/K191477
Methodology: https://510kreport.com/methodology