# K180056: Genesys Spine AIS-C Cervical Anchored Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Mar 28, 2018 after 79 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: 15 generations back to K841189 (1984). 132 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152099: Genesys Spine Apache® Anchored Cervical Interbody Fusion System, Genesys Spine (2016) Summary page 4.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 4.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 4.
- K132582: Exactech Acapella One Cervical Spacer System, Exactech, Inc. (2014) Summary page 4.
- K141314: Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation, Spineart (2014) Summary page 4.
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 4.

## Most influential descendants
- K181295: Genesys Spine AIS-C Cervical Stand-Alone System (2018), 17 descendants of its own
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own
- K181621: Stable-C Interbody System (2018), 7 descendants of its own
- K231763: Stable-C Interbody System (2023), 6 descendants of its own
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (2023), 5 descendants of its own

## Indications for use
The Genesys Spine AIS-C Cervical Anchored Interbody 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 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/K180056
Methodology: https://510kreport.com/methodology