# K242483: Genesys Spine AIS-C II Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Feb 7, 2025 after 170 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). 364 ancestors in all.
No later device cites it as a predicate yet.
1 of 365 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181295: Genesys Spine AIS-C Cervical Stand-Alone System, Genesys Spine (2018) Summary page 5.
- K233594: Genesys Spine 3DP AIS-C II Cervical Interbody System, Genesys Spine (2023) Summary page 5.

## Indications for use
When used with the integrated fixation and as a standalone system: The Genesys Spine AIS-C Il Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine AIS-C Il Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach. When used without the integrated fixation: The Genesys Spine AIS-C Il Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2—T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e., cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K242483
Methodology: https://510kreport.com/methodology