# K212450: Keos Anterior Cervical Interbody Fusion Device System

- Pathway: 510(k) (Traditional)
- Applicant: Keos
- Decided: Jun 6, 2022 after 305 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: 22 generations back to K841189 (1984). 320 ancestors in all.
No later device cites it as a predicate yet.
1 of 321 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200458: Tailored-C Cervical Interbody Fusion System, Bespoke Technologies (2020) Summary page 5.
- K142345: Talos-C (HA) Cervical Intervertebral Body Fusion Devices, Meditech Spine, LLC (2015) Summary page 5.

## Indications for use
The Keos Anterior Cervical Interbody Fusion Devices (IBFDs) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Keos Anterior Cervical IBFD's are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autogenous bone graft. Keos Anterior Cervical IBFD's are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. 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/K212450
Methodology: https://510kreport.com/methodology