# K181295: Genesys Spine AIS-C Cervical Stand-Alone System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Aug 29, 2018 after 105 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: 16 generations back to K841189 (1984). 133 ancestors in all.
17 later devices descend from it; 5 cite 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)
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 4.
- K180056: Genesys Spine AIS-C Cervical Anchored Interbody System, Genesys Spine (2018) Summary page 4.
- K152099: Genesys Spine Apache® Anchored Cervical Interbody Fusion System, Genesys Spine (2016) Summary page 4.
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 4.

## Most influential descendants
- 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
- K240416: Tranquil-C Interbody System (2024), 3 descendants of its own

## Indications for use
The Genesys Spine Cervical Stand-Alone 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 Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.

Source page: https://510kreport.com/device/K181295
Methodology: https://510kreport.com/methodology