# K233594: Genesys Spine 3DP AIS-C II Cervical Interbody System

- Pathway: 510(k) (Special)
- Applicant: Genesys Spine
- Decided: Dec 13, 2023 after 35 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: 25 generations back to K841189 (1984). 363 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 366 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191489: Genesys Spine 3DP Cervical Interbody System, Genesys Spine (2020) Summary page 4.

## Most influential descendants
- K261882: Pisces-SC Standalone Cervical Interbody System (2026), 0 descendants of its own
- K242483: Genesys Spine AIS-C II Cervical Interbody Fusion System (2025), 0 descendants of its own

## Indications for use
When used with the integrated fixation and as a stand-alone system: The Genesys Spine 3D Printed AIS-C II Cervical Interbody Fusion System is a stand-alone 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 3D Printed AIS-C II 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 3D Printed AIS-C II 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/K233594
Methodology: https://510kreport.com/methodology